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Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware, USA - Massachusetts - Waltham Posted Date: Dec 18 2025 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. The Device Lead, Technology and Innovation will serve an important role in developing, networking, and executing our strategies that expand and advance the company's ability to deliver innovative, robust and competitive technologies in drug delivery and combination products across GSK's asset pipelines and portfolio. The ideal candidate shall possess deep knowledge of device technology landscape, technical design/development regimen, and innovative and risk-taking minds. You will work across R&D, Commercial, Global Supply Chain and external partners to explore/ideate, assess, and de-risk GSK's next-wave device technologies, which includes but is not limited to parenteral and respiratory drug deliveries. The direct experience in the development of respiratory drug delivery systems i.e. nebulizers, DPI, pMDI, and SMI is highly desirable. This role will sit in our Device Technology and Innovation group, and offer growth, visible impact on patient-centric solutions, and alignment with GSK's mission of uniting science, technology and talent to get ahead of disease together. This position will be based at one of GSK's R&D sites in Upper Providence, Pennsylvania (US), Waltham, Massachusetts (US) or Ware, Hertfordshire (UK) and is offered as a hybrid position with an expectation to be on-site 2-3 days per week, and occasional travel may be required. Responsibilities:<ul><li>Monitor and analyze external market trends, competitive landscape, and emerging technologies to ensure access to cutting edge drug delivery technologies which are strategic to delivery GSK pipeline.</li><li>Lead specific pipeline asset-based device technology exploration, assessment, and feasibility studies while engaging with Early Engagement and Device-ability, Device Engineering, Primary Packaging, Formulation and Patient Insight Subject Matter Experts (SMEs).</li><li>Define and deliver technology development plans, including scope, schedule, budget and milestones.</li><li>Coordinate cross-functional teams and external partners to progress design, prototyping, testing and manufacturability assessments.</li><li>Identify technical risks and lead mitigation activities using test programs, simulation, technical deep dive, and project and functional governance reviews.</li><li>Communicate results and recommendations clearly to stakeholders and senior leadership.</li><li>Manage a network of external technologic partners and engineering vendors to help accelerate innovation and both build and expand GSK's drug delivery device capability.</li><li>Help drive an internal culture of innovation, including developing and curating a portfolio of problem statements across the portfolio, leading structured ideation sessions, and encouraging creativity.</li></ul>Why You? Basic Qualifications: We are seeking professionals with the following required skills and qualifications to help us achieve our goals:<ul><li>Bachelor's degree in Mechanical, Biomedical, Chemical Engineering or a related technical field.</li><li>10 or more years of relevant industry experience in medical device or drug-device combination development.</li><li>Experience with parenteral delivery devices such as pre-filled syringes, autoinjectors, and on-body injectors.</li><li>Experience leading technology assessments, feasibility studies, or early-stage device programs.</li><li>Experience with design and development of medical device from early concept to launch phases, preferably in the drug delivery space.</li><li>Experience with regulatory requirements for parenteral/respiratory combination products (21 CFR Part 4 & 820, ISO 13485, 14971 & IEC 62366).</li><li>Experience working with external partners, suppliers or contract manufacturers.</li><li>Experience with regulatory requirements for combination products and medical devices.</li></ul>Preferred qualifications:<ul><li>Advanced degree (master's or PhD) in an engineering or related discipline with a minimum of 5 years of relevant industry experience.</li><li>Strong collaboration and communication skills, with experience working in cross-functional teams.</li><li>Experience with respiratory delivery devices such as Nebulizers and inhalers such as pMDI, DPI and soft mist inhalers.</li><li>Self-motivated and organized, knowledgeable of relevant scientific literatures, passionate about the patients we serve, creative, open-minded, highly motivated results-orientated and have high learning agility.</li><li>Both technically strong and possess strong business acumen, with a proven track record in the successful innovation, development and commercialization of combination devices from both a technical and strategic perspective.</li><li>Strong verbal, written, and interpersonal communication skills, with ability to lead through matrix team and influence decisions at all levels</li></ul>How we work here You will join a multi-skilled, collaborative team that values learning and practical solutions. You will have the chance to grow your skills in technical leadership, program delivery and stakeholder engagement. We welcome people who bring diverse perspectives and who want to help build solutions that make a real difference for patients. Apply now If you are ready to lead device technology and innovation and help shape the next generation of patient-centric solutions, we want to hear from you. Please apply and tell us how your experience matches this role. #LI-GSK &bull; If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $138,600 to $231,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call. Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

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Device Lead, Technology and Innovation

Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, UK - London, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - North Carolina - Durham Posted Date: Dec 18 2025 The Director, Global Content Design and Delivery, Vaccines in the Global Scientific Communications organization is responsible for chairing Global Integrated Medical Communication Teams (GIMCT) for the Vaccines asset/disease area and driving the development of Integrated Medical Communication Plans (IMCP). This includes the creation of content, channel, and congress plans/tactics, ensuring the timely execution of deliverables such as the Scientific Communication Platform (SCP), Scientific Narrative, content and channel plans, and associated congress tactics. This role will ensure the delivery of scientifically accurate, evidence-based, and compliant materials for healthcare professionals, patients, and internal teams. Key Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following. &bull; Chair the Global Integrated Medical Communication Teams (GIMCT) for assigned assets/therapeutic areas to drive the development of Integrated Medical Communication Plans (IMCP), inclusive of content, channel, and congress plans/tactics. &bull; Drive key asset deliverables including the Scientific Communication Platform (SCP), Scientific Narratives, Content and Channel plans, Congress Plans and all associated tactics. &bull; Serve as a key partner to therapeutic area medical leaders, global publications, R&D, Global Medical Team (GMT), and priority markets and regions. &bull; Collaborate with internal stakeholders on the development and execution of innovative tools for internal and external communication, including digital/social medical delivery. &bull; Drive timely execution of all deliverables within the IMCPs for assigned assets, ensuring they are scientifically accurate, evidence-based, and comply with relevant regulations, industry guidelines, and ethical standards. &bull; Accountable for aligning with key stakeholders and for the input of the IMCP framework and related engagement planning elements within the asset annual business planning process. &bull; Lead annual scope of work development with procurement for IMCP deliverables with agencies of record, and provide continuous oversight and feedback to drive effective collaboration and partnership &bull; Ensure content development follows all relevant codes and system requirements (e.g. ABPI code of practice, GSK Code, and use of Content Lab), particularly with respect to the delivery of promotional versus non-promotional information. &bull; Participate in initiatives on Gen AI platforms being leveraged for content creation and personalization/adaptation to ensure broader scalability and use &bull; Gather and share best practices across Global to ensure consistency, high standards, and excellence are maintained across the organization. &bull; Stay updated on advancements in scientific communications to ensure content approaches evolve with the external landscape. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> Advanced Life Sciences degree in science, medicine, or pharmacy is required. </li><li> 7 or more years of related experience in scientific communications, medical content design and delivery, within the pharmaceutical or healthcare industry. </li><li> Experience in leading cross-functional teams and driving strategic end to end communication plans. </li><li> Develop and execute innovative communication tools, including digital and social media strategies. </li><li> Project management skills with the ability to manage multiple projects. </li><li> Experience in developing and delivering medical training materials and presentations to HCPs and senior leadership. </li><li> Experience in digital content creation and management tools with solid technical capabilities in Excel, PowerPoint, and Team sites. </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li> Postgraduate degree (PhD or PharmD). </li><li> Local, regional, or global medical or R&D experience with relevant expertise in Vaccines therapeutic area. </li><li> Scientific communication strategies for large global markets in US, UK, EU, China and Japan. </li><li> Ability to interpret, analyze, organize, and present complex data to a broad range of audiences. </li></ul> #LI-GSK &bull; If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $187,275 to $312,125. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call. Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Director, Global Content Design and Delivery, Vaccines

Site Name: Durham Blackwell Street Posted Date: Dec 18 2025 We are a specialist pharmaceutical company fully dedicated to developing medicines to treat and prevent HIV. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, our ambition is to end the HIV epidemic. As the pioneers in HIV innovation, we constantly look to push the boundaries of science to develop medicines that can change lives and give people more choice. Beyond our medicines, we are proud of our deep connection with the HIV community and work with partners to advance research and development, address HIV-related stigma, increase access to our medicines and provide funding and support to local community organisations to support their efforts in the HIV response. We are ViiV Healthcare. Here until HIV and AIDS are not. You will design, build, and deploy machine learning models and AI solutions at scale to accelerate the commercialization of our products. You will collaborate with data scientists, data engineers, product managers and marketing leads to translate real-world problems into clear ML solutions. You will drive measurable impact, grow your skills and help GSK unite science, technology and talent to get ahead of disease together. Responsibilities This role will focus on development and deployment of AI and ML solutions for the commercial organization at scale. The responsibilities for this role include:<ul><li>Develop and deploy machine learning models for commercial, scientific and operational problems.</li><li>Design and implement scalable, production-ready AI and ML solutions</li><li>Design and run experiments to measure the impact of models on key business metrics</li><li>Collaborate with cross-functional teams to translate domain needs into clear technical requirements.</li><li>Build reliable, tested, and maintainable code and services for model training and inference.</li><li>-Implement scalable data pipelines and ensure model data quality, versioning, and reproducibility.</li><li>Monitor model performance in production and iterate to improve reliability and fairness.</li><li>Contribute to team standards for ML engineering, testing, and documentation.</li></ul> We are seeking candidates who want to make a real impact through applied machine learning. This is a hybrid-role based out of Durham, NC. We welcome applicants from different backgrounds and experiences who bring humility, collaboration, and a commitment to learning. Why You? Basic Qualifications We are seeking professionals with the following required skills and qualifications to help us achieve our goals<ul><li>Bachelor's Degree in Computer Science, Applied Mathematics, Engineering, or equivalent practical experience.</li><li>5+ years of experience building and deploying machine learning and AI models in production.</li><li>Experience in Python, SQL and experience with at least one deep learning framework (PyTorch, TensorFlow, or similar).</li><li>Experience in one or more of the follow fields of applied ML - Recommendations, Personalization, Large Language Models (LLMs), LLM Evals</li><li>Experience with cloud technology stack (eg Azure, GCP or AWS) and ML development environments (eg DataBricks, MLFlow)</li><li>Software engineering practices: testing, code reviews, CI/CD, and containerization.</li></ul>Preferred Qualifications If you have the following characteristics, it would be a plus:<ul><li>Advanced degree (Masters or PhD) in Machine Learning, Computer Science, or related field.</li><li>Experience with patient data, payer data, clinical data and familiarity with relevant data formats.</li><li>Experience optimizing models for scale, latency, and cost</li><li>Experience in managing ML and AI in production including data drift tracking, model governance, validation, and responsible AI practices.</li><li>Track record of shipping ML-powered products or services in industry.</li><li>Contributions to open-source projects or peer-reviewed publications.</li><li>Clear communication skills and experience working with cross-functional teams.</li></ul>We want to hear from you. If you are ready to apply your machine learning skills to work that matters, please apply and tell us how you can contribute to our mission. #LI-ViiV Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee. Why Us? At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 40 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV. We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK. Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call. Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive ViiV is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

ViiV (GSK) Machine Learning Engineer

Summary Manage Quality aspects of clinical programs and projects within area of responsibility. Ensure and support overall GxP conformity and Compliance with the Novartis Quality Management Systems. Identify and execute on OpEx opportunities. Build/manage stakeholder relationships and expectations About the Role Location: Durham, NC #LI-Onsite Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Major accountabilities: <ul><li> Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting -Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner -Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual -Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. </li><li> Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality. </li><li> Contributes to an improvement of current processes and/or to an implementation of modified processes. </li><li> Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate. </li><li> Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments -Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation Supports Compliance review of projects and inspection readiness and management -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) </li></ul> Key performance indicators: <ul><li> In accordance with departmental objectives such as support of projects with agreed quality and delivery date -passing of internal and external inspections. </li><li> Maintain sound working relationships with partners and customers -Demonstrated/recognized leader of specific GxP; early external/industry engagement -Basic financial knowledge (e.g., cost management, budget forecast, etc.) -Role Model of Novartis culture, values & behaviors for his/her department </li></ul> Minimum Requirements: Work Experience: <ul><li> Functional Breadth. </li><li> Collaborating across boundaries. </li><li> Operations Management and Execution. </li><li> Project Management. </li></ul> Skills: <ul><li> Agility. </li><li> Audit Management. </li><li> Business Partnering. </li><li> Change Control. </li><li> Continuous Learning. </li><li> Health Authorities. </li><li> Influencing Skills. </li><li> Knowledge Of Capa. </li><li> Qa (Quality Assurance). </li><li> Quality Management. </li><li> Quality Management Systems (Qms). </li><li> Risk Management. </li><li> Root Cause Analysis (Rca). </li><li> Self Awareness. </li><li> Sop (Standard Operating Procedure). </li><li> Technological Expertise. </li></ul> Languages : <ul><li> English. </li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $77,000 and $143,000 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Specialist, Quality Control Microbiology

Summary The Senior Automation Engineer reports to the AD Process Automation and is responsible for providing automation design team leadership and serving as a technical subject matter expert for a Novartis Aseptic Drug Product facility. About the Role Location: This position will be located in Durham, NC and will be an On-Site role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities:<ul><li>Ensure automation aspects of new equipment are appropriately designed, meet Novartis standards and are appropriately commissioned and qualified.</li><li>Provide oversight for automation aspects of projects including integration of 3rd party equipment to other standard plant systems, e.g., DCS, BMS, Historian, Infrastructure.</li><li>Provide design, configuration, installation, and maintenance of automation software and associated hardware for existing equipment and processes.</li><li>Prepare scopes of work for large projects, lead small teams and manage automation contractors as required to complete required work within project timelines.</li><li>Lead discussions with internal business partners on priorities, timelines and transparent sharing of information.</li><li>Develop, review and approve lifecycle documentation, e.g., User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).</li><li>Develop and maintain procedures to meet GMP requirements, CFR's and internal company policies.</li><li>Participate and/or lead new product implementation processes to ensure smooth transition from process development into GMP manufacturing.</li><li>Drive operational excellence and continuous improvement.</li><li>Partner with Quality to ensure a quality and compliant manufacturing environment including participation in regulatory audits as an automation SME.</li><li>Solve technical related issues impacting production.</li><li>Support 24x7 site-based operations including rotating on-call responsibilities.</li><li>Support investigations of non-conformances related to automation systems.</li><li>Other related duties as assigned.</li></ul>Essential Requirements:<ul><li>B.S. degree in Engineering, Computer Science, or related technical field.</li><li>8 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (12 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations.</li><li>Excellent oral and written communication skills, including demonstrated technical writing skills.</li><li>Experience programming, troubleshooting, and maintaining various site automation systems including DCS, BMS, PLC, SCADA, historian, infrastructure, including use of various industrial protocols.</li><li>Experience in development and execution of system level qualification testing including providing guidance on qualification plans in conjunction with C&Q department.</li><li>Proven experience applying S88 in an automated environment and development of control system standards aligning with S88 methodology.</li><li>Experience in field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and experience with instrumentation.</li><li>Experience writing and executing complex change controls.</li><li>In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.</li><li>Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.</li><li>Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.</li><li>Provide technical support on all manufacturing issues when driving towards issue resolution.</li><li>Up to 10% travel may be required.</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $103,600 and $ 192,400 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Senior Engineer, Automation

Summary The Senior Manager, CGT ITOT/Automation, reports to the AD, Process Automation and leads a team of site-based automation engineers to install, maintain and support automation systems primarily associated with Aseptic Drug Product equipment and facilities. About the Role Location: This position will be located in Durham, NC and will be an On-Site role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities:<ul><li>Leads automation processes for the design, installation, maintenance and support of process equipment and automation systems.</li><li>Continuously improves and seeks innovation related to site automation systems.</li><li>Executes automation strategy and proper system management per global Novartis standards.</li><li>Owns computerized systems for process related equipment.</li><li>Manages engineers supporting 24/7 operations providing clear, consistent leadership, management and mentoring.</li><li>Develops, monitors and improves KPI's for system reliability.</li><li>Change management and CAPA ownership to drive continuous improvement for automation systems.</li><li>Leads SME's for deviation investigations involving automation systems.</li><li>Leads SME's for automation systems in regulatory audits.</li><li>Ensures training curriculum is optimized and ensures cross training of individuals across the team.</li><li>Supports creation of standard lifecycle documentation, e.g., User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS), etc.</li><li>Works closely with operations and manufacturing sciences to evaluate new product introductions and impact to automation systems.</li><li>Supports the development of site facility and equipment master plans, network business processes associated with automation systems, and GTx Engineering initiatives or programs.</li><li>Other related job duties as assigned.</li></ul>Essential Requirements:<ul><li>Bachelor of Science degree in Engineering or other relevant degree with 9 years of experience across multiple ITOT/Automation platforms, e.g., DCS, PLC, SCADA, MES, Historian, as well as experience with process equipment in the drug substance and drug product areas.</li><li>Industry expertise in the design, reliable operation, modification, maintenance, and retirement of computerized systems.</li><li>Demonstrated ability to work and collaborate on cross functional teams (QE, QA, validation, operations) in a fast paced, dynamic team setting.</li><li>Strong interpersonal and excellent verbal and written communication skills are essential.</li><li>Knowledgeable of health, safety and environmental regulations, and FDA (and similar) cGMPs.</li><li>Planning, problem analysis, and decision-making skills.</li><li>Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS).</li><li>Self-motivated with a strong sense of ownership in areas of responsibility.</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $108,500 and $ 201,500 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Senior Manager, CGT ITOT/Automation

Summary The Buyer Planner II plays a pivotal role in keeping operations running smoothly. This position oversees the entire journey of inventory materials - from the moment an order is placed to time of delivery, ensuring precision and timeliness every step of the way. Beyond tracking, this role drives innovation by sourcing new materials that power our manufacturing and lab activities, including identifying and partnering with the right suppliers to keep us ahead of the curve. About the Role Location: Durham, NC #LI-Onsite This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you Key Responsibilities: &bull; Perform periodic review of supplier performance and work with his/her manager to alleviate any supplier issues. Periodic review may require setting reoccurring meetings with key suppliers. &bull; Support the Process Science Team by attending weekly production meetings, forecasting material needs and coordinating with the warehouse to ensure materials are available for scheduled production. &bull; Track all raw materials from time of purchase to time of receipt. &bull; Maintain data within the ERP system. &bull; Attend/host regular meetings with suppliers to review open orders/supplier performance. &bull; Accountable for maintaining inventory at planned levels. &bull; Works with manufacturing and lab teams to identify and source new raw materials. &bull; Maintain and update the Item Master as requested. &bull; Create and report key performance metrics related to purchasing and inventory management. &bull; Identifies and sets-up new suppliers through the Supplier Quality Management process. &bull; Work closely with Strategic Procurement to negotiate supply agreements, blanket orders and long-term purchase agreements. &bull; Forecast/Plan material needs to support manufacturing. &bull; Assist Warehouse team with any incoming receipt issues. &bull; Other related duties as assigned. Essential Requirements: &bull; B.S. degree in supply chain, engineering, science, business or related degree or an equivalent combination of education and related experience. &bull; 2 years of supply chain or buyer/planner experience preferred. &bull; Must be able to operate with limited supervision and exercise proper judgment. &bull; Strong communication and organizational skills, detail oriented. &bull; Proficient in MS Office suite of products. &bull; Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. &bull; Approximately 5% travel. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $63,600 and $118,200 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Company will not sponsor visas for this position. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Buyer Planner II

Summary This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. This position will require 20% travel as defined by the business (domestic and/ or international). The Director, Business Excellence Lead will be responsible for providing ongoing strategic, operational, and business planning recommendations/ plans to the Integrated Product Strategy Team (IPST) that will increase impact of our product(s). This unique role will be integrating product and portfolio insights and analytics across functions; and distill the most important insights and actions that drive impact. Lead preparations for critical performance reviews, investor relations and business reviews with various leadership teams; as well as lead cross functional team impact reviews to assess progress against KPIs that are integrated across all functions. Lead strategic core initiatives across the product/ portfolio that will have long lasting impact for patients in need of, or treated with, our products and the ideal candidate is passionate about both strategy, insights and analytics and operational specificity required to translate strategy to impact. This individual will play an integral role in driving excellence in execution across the business. About the Role Key Responsibilities: <ul><li> Run the Integrated Product Strategy, including the setting of priorities, agendas, action items, and follow-ups </li></ul><ul><li> Lead strategic, operational, and business planning recommendations/ plans to GM and leadership teams </li></ul><ul><li> Lead integration of product insights from multiple functions to prioritize the most impactful actions </li></ul><ul><li> Lead preparations for impact reviews with various stakeholders across local and global landscape </li></ul><ul><li> Lead creation of investor relations package and narrative for assigned product(s) </li></ul><ul><li> Lead large cross-functional strategic projects that aim to improve operational efficiency and/or result in significant customer impact </li></ul><ul><li> Partner with finance and insights and analytics to identify criteria for, and measure resource allocation decisions </li></ul><ul><li> Ensures alignment to, compliance with, and ownership of all NPC policies, including the Code of Conduct and all applicable laws and regulations. </li></ul>Essential Requirements:<ul><li> 8+ years in pharmaceutical, biotech, healthcare, or healthcare consulting industry inclusive of at least 2 different types of cross-functional roles/experience </li></ul><ul><li> 2+ years in project management and translation of strategy into execution </li></ul><ul><li> 2+ years leading complex projects requiring global and local alignment </li><li> Education: Bachelor's Degree is required in relevant area, MBA or relevant graduate degree preferred </li></ul>Desirable Requirements:<ul><li> Therapeutic Area experience </li></ul><ul><li> 2+ years within a significant consultancy group ( e.g. McKinsey, BCG, Bain) </li><li> Minimum 5+ year commercial experience preferably with multi -functional experience in a pharmaceutical, biotech, healthcare, or consulting environment </li><li> Demonstrated strategic acumen </li><li> Strong analytical skills and an ability to generate insights and develop relevant action plans </li><li> Strong ability to simplify complex concepts & strategies and tell a story " orally and in writing </li><li> Curious, with excellent listening skills; able to challenge current thinking </li><li> Track record of exceptional performance and execution that drives results </li><li> Ability to lead, manage and motivate teams, with or without authority </li><li> Experience working collaboratively across the matrix </li><li> Strong influencing skills, and the ability to exercise tact and diplomacy in stressful situations </li><li> Ability to manage multiple priorities and a heavy workload </li></ul> The pay range for this position at commencement of employment is expected to be between: $185,500.00 and $344,500.00/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Director, Business Excellence Lead, ASCVD

Summary #LI-Onsite Location: This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible. Join us in shaping the future of pharmaceutical manufacturing! As an Senior Engineer, Utility, you'll play a critical role in ensuring the reliability and efficiency of essential utility systems that power life-changing therapies. This is your opportunity to lead impactful projects, drive innovation, and collaborate with cross-functional teams to maintain world-class standards. Your expertise will help safeguard compliance, optimize performance, and support continuous improvement - making a real difference in patient outcomes and operational excellence. About the Role Key Responsibilities:<ul><li>System ownership responsibilities for site-based utility, electrical, and HVAC systems; including but not limited to water-for-injection, water pre-treatment, chillers, boilers, compressed gases, plant steam/condensate, wastewater, biowaste inactivation, air handling units, cold rooms, switchgear, emergency generators, cooling towers, fire protection, and control systems.</li><li>Oversee installation, maintenance, troubleshooting, and repair of critical facility and utility assets to ensure reliability and minimize downtime.</li><li>Manage equipment changes and upgrades to maintain validated states, ensuring compliance with qualification and regulatory requirements.</li><li>Create, review, and approve essential documentation including SOPs, engineering drawings, maintenance plans, and equipment specifications to support robust operations.</li><li>Investigate non-conformance events and alarm issues, applying root cause analysis and developing effective engineering solutions to prevent recurrence.</li><li>Drive operational excellence initiatives, implementing strategies to optimize system reliability, reduce failure modes, and improve energy efficiency.</li><li>Provide SME-level leadership on projects, guiding all phases from concept through closeout, ensuring timely delivery and adherence to quality standards.</li><li>Collaborate with cross-functional teams including operations, quality, and manufacturing sciences to achieve site objectives and support new product introductions.</li><li>Mentor and coach junior engineers, fostering technical growth and promoting best practices across the engineering team.</li></ul>Essential Requirements<ul><li>B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with a minimum of 8 years' work experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry</li></ul>OR<ul><li>Associate's degree/Diploma/Certification in Engineering Technology or Related Skilled Technical Field, with a minimum of 10 years work experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry</li></ul>OR<ul><li>Equivalent work experience (12+ years) experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry</li></ul>AND<ul><li>Strong technical writing skills and ability to create clear, compliant documentation</li><li>Proven expertise in troubleshooting complex equipment and applying root cause analysis techniques</li><li>Hands-on experience with automated building management systems and industrial PLCs</li><li>Demonstrated ability to lead projects from initiation through completion, ensuring compliance and timely delivery</li><li>Excellent communication and collaboration skills, with a track record of working effectively in cross-functional teams</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $103,600 and $192,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Company will not sponsor visas for this position. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Senior Engineer, Utility

Summary Location: East Hanover, NJ, (Hybrid) #LI-Hybrid This is an on-site role, at minimum 3 days/week. Job Purpose The US People and Organization (P&O) team is seeking a new People Partner to support teams in the Development Business Unit of Novartis. Our People Partners act as a trusted advisors offering in-country policy expertise and knowledge to support and educate leaders, managers and associates on all People and Organization (P&O) topics on the moments that matter. People Partners support divisional customer groups in country enabling the delivery of lifecycle events, the employee value proposition, talent acquisition, talent management, learning, performance management, employee relations, rewards, pay and reporting. In addition, People Partners implement P&O change initiatives at a country level acting as agents of change by working collaboratively with Business Partners and Senior People Partners. We work collaboratively across divisions and adapt our support to meet the evolving needs of the business. About the Role Major Accountabilities: &bull; First point of escalation for all leaders and managers on their day-to-day P&O topics, providing expert advice, guidance and support. Accountable for credible P&O People Partnering to leaders, managers and associates, offering advice and guidance on the moments that matter. Coaches and guides people managers on role evaluations in line with local governance. May consult and advise on Team Effectiveness including Psychological Safety. &bull; Implements P&O initiatives, supporting the overall P&O strategy. Ensure People Partnering processes are accomplished with high quality and efficiency. Champions culture and supports implementation of corporate initiatives. &bull; Drive buy-in and utilization of data and analytics to identify risk and trends, and to apply these business insights to inform decisions and actions. &bull; Embraces customer feedback to understand the customer journey with moments that matter and makes recommendations for continuous improvement. Implement enhancements and modification as necessary to meet both the business and customer needs. &bull; Ensure compliance with local equity / Equal Employment Opportunity (EEO) regulations. &bull; Manage the delivery of in-country transformations, consult with legal, provides advice and guidance for managers through the local US process, oversee associate notice / handover meetings and overall restructuring life cycle. &bull; Manage the execution of local implementation of large-scale organizational and day-to-day organizational structure changes, in line with country regulations / policies. &bull; Ensures local Employee Relations regulations are in line with local regulations and Novartis integrity standards from a cross divisional / country lens. Manages Employee relations within client group, coaching and mentoring associates and managers. &bull; Manage internal movement offers and mobility. &bull; Promotes the contribution of ideas and solutions to the P&O network (Country Business Partners, Global Business Partners and Country P&O Boards). Seeks to establish strong relationships with cross-divisional P&O community members to understand needs and challenges and drive continuous improvement. &bull; Support and coach leaders, manager and associates on all P&O topics including promoting self-sufficiency in people processes. Provides coaching and counselling to Country P&O Business Partners on local policies and processes. What you will bring to the role: &bull; BA Degree in a relevant HR or related discipline. &bull; At minimum 5+ years' work experience in P&O - with breadth of experience across P&O disciplines. At minimum 3+ years supporting a complex and matrix organization within the US. A good understanding of global organizations will be an advantage. HR experience supporting a pharmaceutical or biotech development team is preferred. &bull; Strong Interpersonal skills; Proactive, responsive and ability to work independently with all levels of the organization. Ability to handle multiple conflicting tasks and work in an agile way to support a fast-paced environment is a must. Stakeholder Management and ability to collaborate across boundaries. &bull; Coaching and Mentoring; proficient in facilitation, influencing and collaborating across boundaries. Strong Project management capabilities and people analytics skills, effectiveness with data / metrics / reporting to inform decision making. Employee relations, Risk management and Change management expertise. &bull; Fluency in English both oral and written communication skills. &bull; Experience working in a variety of organizations country wide. The salary for this position is expected to range between $ 98,700 to $183,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

People Partner

Job Description GENERAL SUMMARY : The Sustainability & Utility Engineer is a member of the Plant Engineering team providing direct hands on technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations and hands on troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re-occurrence and help assess the impact on operations. The incumbent will also be responsible for leading plant engineering's sustainability improvement projects and implementation of productivity enhancement initiatives. GENERAL PROFILE: <ul><li> Individual contributor role working with professional employees and/or contractors. </li><li> Contributes to the performance and results of the department. </li><li> Manage the Durham Site's Sustainability portfolio in its entirety involving any of the following: </li><li> Regulatory compliance with internal interpretations </li><li> Manage project strategy for the Durham Site to achieve Net Zero goals based on sustainability Mater Plan </li><li> Develop Business case for sustainability projects to ensure appropriate return in financial and emissions reductions. Determine execution strategy for each </li><li> Develop project execution plan for main components all requirements of the program involving above site commitments and site level commitments. </li><li> Perform ongoing monitoring of systems and ensure returns are being achieved. </li><li> Report on and run governance meetings to manage the program, solicit help and ensure targets are met. </li><li> Execute tasks within the program to achieve plan developed. </li><li> Work with third party vendors and engineering firms to assist in development and completion of any tasks related to program support. </li><li> Perform other maintenance and departmental tasks as required for success like maintenance plan updates, SOP/SBP draft and updating, drawing support, etc </li><li> Adapts departmental plans and priorities to address resource and operational challenges. </li><li> Decisions are guided by policies, procedures and business plan; receives guidance from manager. </li><li> Provides technical guidance to employees, colleagues or contractors </li><li> Anticipates and interprets client and/or customer needs to identify solutions </li><li> Works as a liaison between Plant Engineering and other Site Business Partner's </li><li> Team member for small capital projects for plant engineering </li><li> Obtains bids, reviews contracts, supervises, and follows-up on contract work including. </li><li> Actively Participates in and contributes to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns </li><li> Coordinates with Site Engineering and IPT production planners </li><li> Attends daily shutdown meetings ensuring owned activities are tracked and completed </li><li> Participate in cross-functional teams for engineering Operations projects, or other plant activities as needed. </li><li> Works to streamline and improve Maintenance department systems, procedures and ways of working with a focus on safety, current Good Manufacturing Practices (cGMP) compliance and efficiency. </li><li> Define requirements and specifications for equipment. </li><li> Ability to work independently, set priorities, and drive results at the same time able to work on a production team driving team goals. </li><li> Work hands on to troubleshoot and understand Sustainability impact to the site & utilities systems and equipment issues around the site. </li></ul> BUSINESS EXPERTISE: <ul><li> Applies skills to align work activities with department objectives </li><li> Project management (manages project priorities - schedule & cost, installation). </li><li> Extensive industrial experience involving utility system generation, distribution and controls are needed. Engineer must be have in depth experience (without further skills training) working with industrial utility generation equipment - Boilers, Chillers, Compressors, Pumping distribution systems, etc </li><li> Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.) </li><li> Actively search for ideas and ways to reduce expenses and improve quality without compromising superior customer service. </li></ul> FUNCTIONAL EXPERTISE: <ul><li> Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment up-time, minimizing cost and maintaining process consistency </li><li> Perform a thorough review of design & engineering records and related Good Manufacturing Practices documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process for equipment. </li><li> Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance. </li><li> Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet current Good Manufacturing Practices requirements. </li><li> Knowledgeable of all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions for Utilities and the commissioning of that equipment. </li></ul> PROBLEM SOLVING: <ul><li> Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units </li><li> The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause and then fix then fix implement corrective and preventative actions to prevent repeat failures. </li><li> Responsible for the identification, development, and implementation of new systems which enhances the operation of Plant Engineering processes. </li><li> Assist with trouble shooting Plant Engineering equipment on an as needed basis which includes but limited to chillers, boiler, AHUs, PLCs, humidifiers/dehumidifies, water systems, Square D controllers/monitors, clean steam generators, refrigeration systems, and cryogenic storage. </li><li> Perform engineering task as needed to maintain plant utilities equipment. </li></ul> IMPACT : <ul><li> Explains difficult concepts and persuades others to adopt point of view. </li><li> Communicates information, asks questions and checks for understanding. Provide clarification in person and in writing for streamlined communication. </li></ul> ACCOUNTABILITY <ul><li> Accountable for the their own performance and performance of sustainability program & support of plant engineering systems and maintenance. </li></ul> DECISION MAKING <ul><li> Makes decisions - guided by policies, guidelines, design practices, and procedures - that impact the department's ability to meet performance objectives </li><li> Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes </li></ul> STRATEGIC PLANNING: <ul><li> Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges </li><li> Consults on an as-needed basis with next-level manager for newly identified priorities. </li><li> Lead initiatives and see through to completion. </li><li> Responsible for the identification and implementation of preventative and predictive maintenance programs to assure compliance with quality, regulatory, and reliability requirements and goals. </li><li> Utilize maintenance and reliability metrics and key performance indicators. Benchmark performance indicators against industry data. Look for continuous improvements opportunities </li></ul> RESOURCE MANAGEMENT: <ul><li> Forecasts resource needs; manages allocated expense budgets for tasks </li><li> Forecasts resource needs; manages allocated resources to implement projects </li><li> Working Relationships </li><li> Reports to Plant Engineering Manager </li><li> Frequent interaction with employees from other departments </li><li> Interacts with representatives from regulatory agencies </li><li> Collaborates with the production area maintenance technicians and engineers to maintain utility up-time for all production equipment. </li><li> Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, Good Manufacturing Practices (GMP), and calibration/maintenance procedures. </li><li> Establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities </li><li> Assists in deviation investigations for maintenance instruments, equipment, and systems. </li></ul> Position Qualifications: Education Minimum Requirement: <ul><li> Bachelor's Degree in Engineering, Science or related field </li></ul>Required Experience and Skills:<ul><li> Five years of experience in a production and/or calibration and/or maintenance background </li><li> Strong planning, scheduling, and time management skills </li><li> Good oral and written communication skills </li><li> SAP experience related to plant maintenance and spare parts procurement systems </li><li> Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA, and/or Lean Six Sigma tools. </li><li> Familiarity of World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.) </li><li> Fully proficient in understanding the functionality of all utility generation equipment (e.g. electrical distribution, clean utilities - Boilers, Chillers, wfi/clean steam, HVAC/R, and utility generation equipment. </li><li> Utility and HVAC system process improvement and optimization experience </li><li> Technical writing and deviation investigation experience </li><li> Experience in managing a project portfolio and/or a program with strategic initiatives. </li><li> Experience in problem solving and troubleshooting </li><li> Familiarity with cGMPs and vaccine regulatory requirements. </li></ul> Preferred Experience and Skills: <ul><li> Sustainability SME and related certifications </li><li> CMMS experience related to plant maintenance and spare parts procurement systems </li><li> Project management, including change control and equipment qualification </li><li> SAP experience related to plant maintenance and spare parts procurement systems </li><li> Familiarity with current Good Manufacturing Practices experience in a sterile, bulk or finished pharmaceutical environment </li><li> Experience in automation and manufacturing execution systems (MES), process modeling and process improvement. </li><li> Mechanical functionality and reliability knowledge (asset management) </li><li> Green Belt/Black Belt Certification </li><li> Professional Engineer VetJobs #EBRG's </li></ul>Required Skills: Accountability, Accountability, Adaptability, Capital Project Management, cGMP Regulations, Change Management, Communication, Curriculum Development, Data Analysis, Engineering Processes, Equipment Qualification, Facility Management, Good Manufacturing Practices (GMP), Leadership, Maintenance Supervision, Occupational Safety and Health, Process Improvement Projects, Productivity Improvements, Project Management, Regulatory Audits, Regulatory Compliance, Sterile Manufacturing, System Maintenance, Team Leadership, Third Party Vendors {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/9/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378154

Senior Specialist Sustainability & Utility Engineer

Job Description We are seeking a motivated and experienced Translational PET Imaging Scientist to lead the transition of novel PET radiotracers from late preclinical development into first-in-human studies. This role will primarily focus on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project teams to ensure efficient clinical translation. Key Responsibilities:<ul><li> Strategy & leadership : Develop and lead the clinical imaging strategy for application of novel PET tracers in early clinical oncology trials, guiding projects from late-stage preclinical work through clinical proof-of-concept studies.</li><li> Translational study design : Design, oversee, and interpret PET imaging studies in animal models and early-phase clinical trials (Phase I), ensuring robust study design and high-quality PET data collection.</li><li> Regulatory support : Familiarity with regulatory and quality frameworks applicable to radiopharmaceuticals (GMP for radiopharmaceuticals, IND/CTA requirements, radiation safety/compliance). Prepare and contribute PET-specific scientific content for regulatory filings, including IND submissions.</li><li> Partner and site management : Coordinate with CROs, CDMOs, and clinical sites to support cGMP manufacturing logistics and clinical supply/distribution for radiopharmaceuticals. Manage relationships and deliverables with external academic collaborators and CROs/CDMOs</li><li> Cross-functional collaboration : Serve as the PET imaging subject-matter expert on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs, clinical operations, and CMC teams.</li><li> Reporting & dissemination : Interpret imaging data, author study reports, present findings internally and externally, and contribute to manuscripts and conference presentations.</li></ul>NOTE: This role is available in South San Francisco, CA; Boston, MA; West Point, PA or Rahway, NJ based on candidate preference. Qualifications: Education:<ul><li>Ph.D. or equivalent doctorate degree in Biomedical/Imaging Science, Radiochemistry, Physics, Pharmacology or a related field and seven (7) years of relevant experience.</li></ul>Required Experience and Skills:<ul><li>Demonstrated experience advancing novel PET tracers into clinical studies, including collaboration with academic sites and contract partners for cGMP manufacturing.</li><li>Experience as imaging lead on Phase I oncology trials and direct involvement in first-in-human novel PET tracer studies, including lead contributor to protocol design.</li><li>Strong understanding of radiopharmaceutical development, radiochemistry, and quality control; proven ability designing quantitative PET studies across species.</li><li>First-hand experience with regulatory pathways and requirements for novel PET tracers in early-phase clinical trials.</li><li>Track record of interacting with regulatory agencies or primary contributor to successful agency submissions for novel PET imaging agents.</li><li>Excellent written and verbal communication skills, with a track record of effective collaboration across multidisciplinary teams.</li></ul>#EligibleforERP Required Skills: Cancer Research, Clinical Trials, Oncology, Oncology Trials, Positron Emission Tomography (PET), Project Leadership, Radiation Safety, Radiopharmaceuticals, Radiopharmacy, Regulatory Compliance, Regulatory Work, Technical Leadership, Translational Research Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic/International VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/31/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378617

Principal Scientist, Translational PET Imaging

Job Description Our engineers and scientists support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our technical personnel have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Summary, Focus and Purpose The Vaccines Technology Specialist position is responsible for providing technical support to primary filling, inspection, and/or packaging operations within the vaccine manufacturing facility at the Wilson, NC Site. This position will be an individual contributor and member of the Technical Operations Team within the Rota-POD Integrated Process Team. This is an engineering role focused on the technical & commercial readiness of the vaccine manufacturing facility as well as providing future routine operational support. For their area of assignment, the selected candidate will be the technical subject matter expert for all aspects of tech transfer, validation, licensure, start up, and ongoing technical support. Key Functions Delivery <ul><li>Utilize technical expertise, experience, independent judgment, and decision-making to build robust processes that support consistent and reliable supply</li><li>Resolve and escalate technical issues impacting supply within the daily, weekly, and monthly IPT management processes</li><li>Lead or support equipment process development, troubleshooting and validation activities</li></ul> Compliance <ul><li>Ensure that assigned processes are developed in a robust manner and defined such that vaccines filled at the Wilson site consistently meet critical quality attributes</li><li>Act as or support technical subject matter expert(s) during regulatory inspections for area of assignment</li><li>Ensure that process development and validation data is generated, documented and presented in a manner that supports successful licensure and positive interactions with regulatory agencies</li><li>Lead or support change management for the Rota-POD IPT and provide scientific/technical justification for proposed changes to support business needs</li><li>Investigate, determine root cause, and implement robust Corrective Action and Preventive Actions and author quality investigations for any applicable process related compliance discrepancies noted during day-to-day activities and/or audits, and escalate these issues per IPT management processes</li></ul> Cost <ul><li>Ensure that Technical related activities for area of assignment are managed such that process deliverables and timelines are well defined in advance and met</li><li>Recommend continuous improvement, productivity, and capital projects for the IPT</li></ul> Continuous Improvement <ul><li>Execute projects that support the strategic goals of the Rota-POD IPT</li><li>Maintain a culture of continuous improvement focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving</li></ul>Education<ul><li>Bachelor's degree or higher in Science or Engineering field (Engineering preferred)</li></ul>Required Experience | Knowledge | Skills<ul><li>Two years of relevant industry work experience, with one year experience providing technical/development support to pharmaceutical unit operations</li><li>Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry</li><li>Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols, etc.</li><li>Demonstrated ability to work independently as team member</li><li>Demonstrated strong interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment</li><li>Willing to work irregular hours to support multi-shift operation on an extended or as needed basis</li></ul>Preferred Experience | Knowledge | Skill<ul><li>Experience with aseptic filling, qualified inspection processes, pharmaceutical packaging and/or serialization/aggregation</li><li>Experience in production ramp up of capital projects</li><li>Experience in authoring quality deviations</li><li>Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies</li><li>Familiarity with Change Execution Management tools</li><li>Working knowledge with Systems Applications and Products (SAP) / Manufacturing Execution System (MES)</li><li>Experience working in a Center for Biologics Evaluation and Research (CBER) regulated environment</li><li>Demonstrated data analysis skills and experience setting up process control limits using advanced Excel and/or statistical software packages (Minitab or JMP)</li><li>Experience supporting regulatory inspections including FDA</li></ul>Required Skills: Adaptability, Adaptability, Analytical Instrumentation, Automation Systems, Bioprocessing, Capital Projects, cGMP Compliance, Change Control Processes, Change Request Management, Computerized Maintenance Management Systems (CMMS), Continuous Process Improvement, Data Analysis, Detail-Oriented, Electrical Systems, Global Manufacturing, Lean Manufacturing, Lean Product Development, Maintenance Supervision, Mechanical Systems, Organizational Change Management, Pharmaceutical Packaging, Process Control, Regulatory Compliance, Regulatory Inspections, SAP Manufacturing Execution (SAP ME) {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $85,600.00 - $134,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/5/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R377250

Specialist, Engineering

Job Description Applications are being sought for an associate director position in our Research and Development Division Biologics Pilot Plant (BPP) automation engineering group. Individual will utilize technical expertise to lead and perform various automation activities supporting pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies. Candidate will participate in a range of activities including, but are not limited to: Primary Responsibilities: <ul><li> Provide expertise in multiple automation platforms utilized in the BPP </li></ul><ul><li> Provide technical training and mentoring within the automation group and cross-functional. </li></ul><ul><li> Work with the team to innovate and evaluate new technologies and automation systems to improve the pilot plant's reliability and increase efficiencies </li></ul><ul><li> Author and review GMP change controls, test protocols, SDLC documentation, SOP's, safety reviews, deviation investigations and actions. </li></ul><ul><li> Lead ongoing automation system support and troubleshooting in the facility </li></ul><ul><li> Lead the design, scope, implementation, and GMP close out of pilot plant projects including the specification and automation integration of new equipment, upgrades and improvements. </li></ul><ul><li> Provide automation leadership for GMP clinical manufacturing campaigns in the facility </li></ul><ul><li> Cross-train in many areas and technologies. </li></ul><ul><li> Actively work in a multi-discipline cross-functional project team environment </li></ul> In addition to the core responsibilities outlined above, an opportunity exists to collaborate across our Research and Development Division and our Manufacturing Division with automation and data initiatives. Some off shift (second shift and weekends) will be required to support campaigns. Education Minimum Requirement: <ul><li> Bachelor's degree in engineering with a minimum of 7 years of relevant manufacturing automation experience. </li></ul> Required Experience and Skills: <ul><li> Highly motivated with the ability to work in a fast-paced and dynamic setting. </li></ul><ul><li> Significant experience in multiple BPP automation technologies: Ignition, DeltaV, Rockwell PLC, PI, PI Asset Framework, OPC interfaces, Unicorn, Firewall Rulls, IT/OT technologies and software. </li></ul><ul><li> Demonstrated ability to train individuals and influence functional groups. </li></ul><ul><li> Previous automation experience supporting GMP production of pharmaceuticals, biopharmaceuticals, or vaccines. This includes executing GMP change controls, System Development Life Cycle (SDLC) documentation, and data integrity principles. </li></ul><ul><li> Strong project management, organizational, communication and leadership skills </li></ul><ul><li> Ability to work independently and in a team environment </li></ul> Desired Experience and Skills: Experience with manufacturing equipment, process control, automation infrastructure design, and/or cybersecurity. Experience with integrating equipment automation systems with Enterprise IT managed systems, e.g. MES, virtualization, networking, windows and antivirus patching/updates. Experience with Project Management Methodologies (Agile, Waterfall, etc.) and Tools (MS Project, RACI, GANTT). Experience with building and planning technology road maps. Experience with biologics manufacturing equipment (bioreactors, filtration skids, chromatography skids). Experience supporting GMP audits. PRD Required Skills: Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/9/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R377259

Associate Director, Biologics Pilot Plant Automation

Job Description Discovery Biologics is seeking an Associate Director with experience in biologics and data science to expand our abilities to design and engineer biotherapeutics. We are building a department that directly integrates computational and wet-lab researchers with state-of-the-art automation to accelerate the discovery of novel biologics. We are a highly diverse and collaborative group of biologists, engineers, and computer scientists working at the edge of computation, disease biology, and biotherapeutics. We collaborate broadly within our Company and with academic and industry partners to accelerate the pace of biologics discovery and engineering. We recognize that the diversity in our team is our strength and we are committed to creating an inclusive environment for all employees. Successful candidates must demonstrate inclusive behaviors in working with a diverse group of researchers to drive our core mission. Position Description: This is an individual contributor role with project leadership responsibilities. The successful candidate will work side-by-side with wet-lab researchers to design experiments and build datasets that enable machine learning to predict improved biologics. They will contribute to the identification and application of computational tools that enable the discovery and engineering of biologics. They will partner broadly across Discovery Biologics, Data Science, and IT to implement systems and practices that support high throughput data capture, integration, and the generation of predictive models. As part of project teams, they will analyze diverse multidimensional data to enable teams to drive programs forward. As part of technology development teams, they will pursue novel research that enhances our ability to collect and learn from large datasets. They will mentor, coach, and train fellow researchers. The successful candidate will join a diverse group of innovative researchers who are driving the next revolution in biologics discovery and engineering. Key Responsibilities <ul><li> Develop data science based predictive models for biologics to advance early phase drug discovery programs </li><li> Develop computational routines and custom visualizations that enable project teams to impact protein engineering designs and allow teams to rapidly make program decisions from real-time data </li><li> Collaborate across groups to systematize and automate the process of capturing raw instrument data and preparing it for storage and analysis </li><li> Provide technical expertise and leadership for data science working groups and teams </li><li> Author and contribute to presentations, publications, and patents </li><li> Foster a high-performance culture of collaboration, engagement, self-accountability and inclusion </li></ul> Position Qualifications: Minimum Education Requirement: <ul><li> PhD in Computational Biology, Biostatistics, Biochemistry, Computer Science, Biology, Engineering/Bioengineering, Structural Biology, Biophysics, Chemistry or related STEM discipline with demonstrated expertise in biologics and data science and 4+ years of industry experience </li><li> MS and 8+ years or </li><li> BS +12 years of experience </li></ul> Required Experience: <ul><li> Fluency in at least one modern programming language such as Python, Java or similar; fluency in using version control systems (Git) and branching strategies. </li><li> Strong expertise in data science and data engineering workflow and best practices for life science applications </li><li> Experience working with relational database (SQL) and non-relational database, and designing data models </li><li> Experience in designing, implementing, and maintaining modern data architecture, using the state-of-the-art tools for large scale data applications, such as Airflow, DBT, Kafka, Debezium, Docker, Kubernetes, Datadog </li><li> Extensive experience as a developer using any major cloud platforms (AWS, GCP, Azure) </li><li> Experience in working with microservices and API development </li><li> Ability to teach biologists and biochemists the fundamentals of data science </li><li> Demonstrated ability to succeed in a collaborative, multidisciplinary team environment </li><li> Excellent written and oral communication skills </li><li> Champion for diverse and inclusive culture </li><li> Mentor and coach group members to complement and strengthen their team </li></ul> Preferred Experience and Skills: <ul><li> Experience with NGS data processing and analysis applied to biologics discovery highly preferred </li><li> Full stack developer experience highly preferred </li><li> Experience with Scientific Data Life Cycle (SDLC) documentation highly preferred </li><li> Experience with protein engineering or the discovery and development of biologics </li><li> Experience with multiple types of protein structure and sequence representations, featurization, and embeddings </li><li> Experience with protein modeling software (e.g. AlphaFold, Rosetta, TrRosetta, MOE, GROMACs, or similar) </li><li> Familiarity with data visualization tools and libraries </li><li> Experience in DevOps, DataOps, and ML Engineering </li></ul>#EligibleforERP Required Skills: API Development, Biopharmaceuticals, Computer Science, Data Analysis, Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Programming Languages, Python (Programming Language), Relational Database, Scientific Data Management, Software Development, Stakeholder Relationship Management, Statistics, Structured Query Language (SQL) Preferred Skills: Computational Biology, Full Stack Development, Machine Learning (ML), Next Generation Sequencing (NGS), NGS Data Analysis, Protein Engineering, Protein Modeling, Software Development Life Cycle (SDLC) Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $156,500.00 - $246,300.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/6/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378169

Associate Director , Data Science, Discovery Biologics

Job Description GENERAL SUMMARY : The Utility Engineer is a member of the Plant Engineering team providing direct hands-on technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations and hands on troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re-occurrence and help assess the impact on operations. The incumbent will also be responsible for leading plant engineering's improvement projects and implementation of productivity enhancement initiatives. GENERAL PROFILE: <ul><li>Individual contributor role working with professional employees and/or contractors.</li><li>Contributes to the performance and results of the department.</li><li>Adapts departmental plans and priorities to address resource and operational challenges.</li><li>Decisions are guided by policies, procedures and business plan; receives guidance from manager.</li><li>Provides technical guidance to employees, colleagues or contractors</li><li>Anticipates and interprets client and/or customer needs to identify solutions</li><li>Works as a liaison between Plant Engineering and other Site Business Partner's</li><li>Team member for small capital projects for plant engineering</li><li>Ensures utility operations daily priorities and schedules project/work meeting the criteria established by site objectives.</li><li>Support / lead major utility equipment related projects, scope including funding, change control, integration, commissioning, and equipment qualification</li><li>Obtains bids, reviews contracts, supervises, and follows-up on contract work including.</li><li>Actively Participates in and contributes to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns</li><li>Coordinates with Site Engineering and IPT production planners</li><li>Attends daily shutdown meetings ensuring owned activities are tracked and completed</li><li>systems and process equipment. Provides technical support and training to mechanics and other maintenance personnel.</li><li>Interface with safety, production, and quality groups to ensure facility operations and systems comply with required standards.</li><li>Lead/ participate in discussions with contractors, vendors, or other third-party organizations as necessary to ensure consistency with overall maintenance and reliability objectives.</li><li>Participate in cross-functional teams for engineering Operations projects, or other plant activities as needed.</li><li>Works to streamline and improve Maintenance department systems, procedures and ways of working with a focus on safety, current Good Manufacturing Practices (cGMP) compliance and efficiency.</li><li>Define requirements and specifications for equipment.</li><li>Manage the implementation of new equipment and/or the modifications to existing equipment</li><li>Be the lead with regards to installation, upgrades, and dependability issues, and lead or assist in trouble shooting processes or equipment issues.</li><li>Ability to work independently, set priorities, and drive results at the same time able to work on a production team driving team goals.</li><li>Work hands on to troubleshoot and understand electrical system and equipment issues around the site.</li><li>Assists in deviation investigations for maintenance instruments, equipment, and systems</li></ul> BUSINESS EXPERTISE: <ul><li>Applies skills to align work activities with department objectives</li><li>Project management (manages project priorities - schedule & cost, installation).</li><li>Extensive industrial experience involving utility system generation, distribution and controls are needed. Engineer must be have in depth experience (without further skills training) working with industrial utility generation equipment - Boilers, Chillers, Compressors, Pumping distribution systems, etc</li><li>Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.)</li><li>Actively search for ideas and ways to reduce expenses and improve quality without compromising superior customer service.</li></ul> FUNCTIONAL EXPERTISE: <ul><li>Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment up-time, minimizing cost and maintaining process consistency</li><li>Provide input to investigate deviations (both minor and major), with responsibility to interface with Operations, Global Vaccine Technology (GVTE), Automation, and Quality approvers. </li><li>Perform a thorough review of design & engineering records and related Good Manufacturing Practices documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process for equipment.</li><li>Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance.</li><li>Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet current Good Manufacturing Practices requirements.</li><li>Knowledgeable of all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions for Utilities and the commissioning of that equipment.</li></ul> PROBLEM SOLVING: <ul><li>Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units</li><li>The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause and then fix then fix implement corrective and preventative actions to prevent repeat failures.</li><li>Responsible for the identification, development, and implementation of new systems which enhances the operation of Plant Engineering processes.</li><li>Assist with trouble shooting Plant Engineering equipment on an as needed basis which includes but limited to chillers, boiler, AHUs, PLCs, humidifiers/dehumidifies, water systems, Square D controllers/monitors, clean steam generators, refrigeration systems, and cryogenic storage.</li><li>Perform engineering task as needed to maintain plant utilities equipment.</li></ul> IMPACT :<ul><li>Influence</li><li>Explains difficult concepts and persuades others to adopt point of view.</li><li>Communicates information, asks questions and checks for understanding. Provide clarification in person and in writing for streamlined communication.</li></ul> ACCOUNTABILITY <ul><li>Accountable for their own performance and performance of plant engineering systems and maintenance.</li></ul> DECISION MAKING <ul><li>Makes decisions - guided by policies, guidelines, design practices, and procedures - that impact the department's ability to meet performance objectives</li><li>Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes</li></ul> STRATEGIC PLANNING: <ul><li>Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges</li><li>Consults on an as-needed basis with next-level manager for newly identified priorities.</li><li>Lead initiatives and see through to completion.</li><li>Responsible for the identification and implementation of preventative and predictive maintenance programs to assure compliance with quality, regulatory, and reliability requirements and goals.</li><li>Track maintenance and reliability metrics and key performance indicators. Benchmark performance indicators against industry data. Look for continuous improvements opportunities</li></ul> RESOURCE MANAGEMENT: <ul><li>Forecasts resource needs; manages allocated expense budgets for tasks</li><li>Forecasts resource needs; manages allocated resources to implement projects</li><li>Working Relationships</li><li>Reports to Plant Engineering Manager</li><li>Frequent interaction with employees from other departments</li><li>Interacts with representatives from regulatory agencies</li><li>Collaborates with the production area maintenance technicians and engineers to maintain utility up-time for all production equipment.</li><li>Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, Good Manufacturing Practices (GMP), and calibration/maintenance procedures.</li><li>Establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities</li><li>Assists in deviation investigations for maintenance instruments, equipment, and systems.</li></ul> Position Qualifications: Education Minimum Requirement:<ul><li>Bachelor's degree in engineering, Science or related field</li></ul>Required Experience and Skills:<ul><li>Five years of experience in a production and/or calibration and/or maintenance background</li><li>Strong planning, scheduling, and time management skills</li><li>Working knowledge regulatory requirements in accordance with GMP manufacturing operations</li><li>Good oral and written communication skills</li><li>Experience with GMP compliant calibration and maintenance databases</li><li>SAP experience related to plant maintenance and spare parts procurement systems</li><li>Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA, and/or Lean Six Sigma tools.</li><li>Familiarity of World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.)</li><li>Fully proficient in understanding the functionality of all utility generation equipment (e.g. electrical distribution, clean utilities, Boilers, Chillers, wfi/clean steam, HVAC/R, and utility generation equipment.</li><li>Utility and HVAC system process improvement and optimization experience</li><li>Technical writing and deviation investigation experience</li><li>Experience in problem solving and troubleshooting</li><li>Familiarity with cGMPs and vaccine regulatory requirements.</li></ul>Preferred Experience and Skills:<ul><li>CMMS experience related to plant maintenance and spare parts procurement systems</li><li>Project management, including change control and equipment qualification</li><li>SAP experience related to plant maintenance and spare parts procurement systems</li><li>Familiarity with current Good Manufacturing Practices experience in a sterile, bulk or finished pharmaceutical environment</li><li>Experience in automation and manufacturing execution systems (MES), process modeling and process improvement.</li><li>Mechanical functionality and reliability knowledge (asset management)</li><li>Green Belt/Black Belt Certification</li><li>Professional Engineer VetJobs #EBRG's</li></ul>Required Skills: Adaptability, Business Planning, Capital Project Management, cGMP Regulations, Change Management, Curriculum Development, Data Analysis, Deviation Investigations, Equipment Qualification, Facility Management, Good Manufacturing Practices (GMP), Implementation Management, Maintenance Supervision, Occupational Safety and Health, Process Improvement Projects, Productivity Improvements, Project Management, Regulatory Audits, Sterile Manufacturing, System Maintenance, Team Leadership, Troubleshooting, Utility Plant Operations Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/9/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378155

Senior Specialist, Engineering

Job Description Associate Specialist - MACS Operations Specialist (P1) Description The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The MACS Operations Specialist position will report to the Associate Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities of the Operations Specialist include the following: The Operations Specialist role at the Associate Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant under construction in Rahway, New Jersey. They will serve as a team member for the MACS Center construction and startup phase and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network. As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, equipment or material testing, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup. Additionally, the selected candidate will be a key contributor to the Operational Readiness program with the purpose of establishing the procedures, documentation, and training necessary to operate and maintain a new business area after completion of the facility startup. The selected candidate is expected to be a key part of the operations team and foster a culture of collaboration, learning and innovation. They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies. Once the MACS Center is operational, additional tasks could include equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge capture, and troubleshooting equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of reagents, solvents, and active pharmaceutical ingredients during wet chemistry" operations (performing chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) as well as dry powder processing (e.g., dry milling). Additional Supported Areas As required and in addition to support of current capital projects the Associate Specialist may provide direct support to other areas such as: Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. Prep Lab Area : The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. The Prep Lab includes a cleanroom suite for GMP small-scale manufacturing of potent and multi-modality clinical materials. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space. Education Minimum Requirement: Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field plus one (1) year relevant work experience - OR - Associate in Science, Associate in Applied Science (ideally in Process Technology), or Associate degree in a relevant technical field of study plus at least six (6) years experience - OR - High School Diploma/GED plus at least eight (8) years of relevant experience in Pharmaceutical, Chemical, Petrochemical or Food Processing/Manufacturing. Required Experience and Skills: <ul><li> Effective interpersonal and communication skills, both verbal and written. </li></ul><ul><li> Excellent organizational skills to multi-task. </li></ul><ul><li> Desire and willingness to learn, contribute and lead. </li></ul><ul><li> Track-record of independent problem-solving. </li></ul><ul><li> Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams. </li></ul><ul><li> A strong mechanical aptitude. </li></ul><ul><li> Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software. </li></ul><ul><li> This role will require working on 8-hour shifts that are currently one common shift across the Operations team but will later rotate between 1st and 2nd shift on alternating weeks as the MACS Center is coming online and in full operations. Onsite presence is required five days a week. Occasional overtime work may be required based on business needs. </li></ul> Desired Experience and Skills: <ul><li> Experience working in a GMP clinical or manufacturing supply facility. </li></ul><ul><li> Experience with GMP facility design, equipment start-up and/or qualification. </li></ul><ul><li> Experience with small molecule drug substance and/or biologics process development. </li></ul><ul><li> Experience in supporting compliance investigations and change management. </li></ul><ul><li> Ability to prepare or leverage Standard Operating Procedures (SOP) and cGMP documents. </li></ul><ul><li> Experience operating/maintaining pilot scale or prep lab scale equipment. </li></ul><ul><li> Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA) </li></ul><ul><li> Experience with Potent Compound processing and containment systems (e.g., isolators), or clean room facilities. </li></ul><ul><li> Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc. </li></ul><ul><li> Experience working in an environment with an Automation System (DeltaV, PLC, etc.). </li></ul><ul><li> Operations experience in pilot plant or manufacturing environment. </li></ul><ul><li> Familiarity with the administration of cGMPs , Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development. </li></ul><ul><li> Lean Six Sigma Training / Certification. </li></ul>#eligibleforERP #PRD PRD MSJR Required Skills: Accountability, Accountability, Applied Engineering, Assembly Operations, Biochemistry, Chemical Engineering, Communication, GMP Compliance, Good Manufacturing Practices (GMP), Hazard Analysis, HR Programs, Machinery Operation, Mechanical Apptitude, Operations Management, Operations Support, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Process Technologies, Production Efficiencies, Production Process Development, Production Scheduling, Raw Material Sampling, Risk Control Assessment, Safety Protocols {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $70,500.00 - $110,900.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/21/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378461

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