Summary Location: Morrisville, NC Step into a pivotal role where your expertise drives the successful launch of life-changing medicines. As a Technical Transfer Lead, you will own and lead complex technology transfer initiatives, shaping how innovative therapies move from development to commercial manufacturing. Working at the heart of a highly collaborative environment, you will partner with cross-functional teams to deliver robust, compliant, and efficient processes-ensuring patients receive high-quality treatments, on time and at scale. About the Role Key Responsibilities<ul><li>Lead end-to-end technical transfer projects, ensuring timelines, scope, and quality objectives are achieved</li><li>Act as site point of contact for transfer activities, aligning stakeholders across Technical Development, Supply Chain, Manufacturing, Quality, HSE, and other sites</li><li>Develop and execute transfer and validation strategies, including process, cleaning, packaging and supportive studies. </li><li>Coordinate technical, regulatory, and validation batches, ensuring documentation readiness and compliance</li><li>Establish and lead cross-functional project teams, driving execution, risk mitigation, and decision-making</li><li>Ensure compliance with cGMP and readiness for inspections and pre-approval audits</li><li>Drive process improvements and optimization to support successful product launches and ongoing manufacturing excellence</li></ul>Essential Requirements<ul><li>Bachelor of Science in Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific degree</li><li>Minimum 5 years of experience in oral solid dosage pharmaceutical manufacturing</li><li>Demonstrated experience in technical transfer, process scale-up, and validation activities</li><li>Strong knowledge of current Good Manufacturing Practices and regulatory requirements</li><li>Proven project management skills with ability to lead cross-functional teams</li><li>Strong technical expertise in pharmaceutical processes, with ability to solve complex manufacturing challenges</li></ul>Desirable Requirements<ul><li>Master of Science or equivalent experience</li></ul>The salary for this position is expected to range between $126,000 - $234,000 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. To learn more about the culture, rewards and benefits we offer our people click here. #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: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) 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.

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Technical Transfer Lead

Summary Step into a role where your expertise directly enables life-changing therapies to reach patients safely and efficiently. As a Validation Engineer III, you will play a critical role in bringing manufacturing systems to life-leading validation efforts that ensure compliance, quality, and operational excellence in a cutting-edge GMP environment. Your work will help build and sustain the foundation for reliable, high-quality production, making a meaningful impact on patients around the world. About the Role Location: <ul><li>This position will be located in Durham, NC and will be an onsite role.</li><li>Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.</li></ul>Key Responsibilities:<ul><li>Lead commissioning, qualification, and validation activities for manufacturing, laboratory, and utility systems</li><li>Author, execute, and review validation protocols, reports, and standard operating procedures</li><li>Oversee user requirement specifications, ensuring compliance, quality, and timely document resolution</li><li>Perform environmental mapping studies and support specialized validation activities</li><li>Analyze validation data to confirm accuracy, completeness, and regulatory compliance</li><li>Develop and support validation strategies and timelines for sustained GMP operations</li><li>Conduct risk and impact assessments to define system boundaries and validation scope</li><li>Own validation lifecycle documentation, including plans, assessments, and final reports</li><li>Support computer systems validation activities for global systems and applications</li><li>Collaborate with cross-functional teams to support audits, inspections, and project execution</li></ul>Essential Requirements:<ul><li>Bachelor's or master's degree in engineering or science with five years of relevant pharmaceutical industry experience</li><li>Proven experience in validation or engineering within a pharmaceutical or biopharmaceutical environment</li><li>Strong knowledge of GMP requirements and validation lifecycle stages</li><li>Hands-on experience with installation, operational, and performance qualification activities</li><li>Familiarity with global regulatory guidelines, including FDA and International Council for Harmonisation standards</li><li>Experience performing environmental mapping and using validation tools such as Kaye Validator</li><li>Experience with biosafety cabinet smoke studies</li><li>Working knowledge of risk-based validation approaches and industry best practices such as ASTM E2500 and GAMP 5</li><li>Excellent technical writing, communication, and problem-solving skills with attention to detail</li></ul>Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $ 98,700 and $183,300 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: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) 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.

Validation Engineer III

Summary Location: Morrisville, North Carolina Join Novartis and play a pivotal role in shaping the future of pharmaceutical manufacturing at our growing Morrisville site. As the Validation Lead, you will drive the site's validation strategy across process, cleaning, packaging, and ongoing verification activities, ensuring products are delivered with the highest standards of quality, compliance, and patient safety. This is a unique opportunity to build and influence validation programs from the ground up, partner with cross-functional experts, and contribute directly to successful product launches, technical transfers, and regulatory readiness in a dynamic and innovative manufacturing environment. About the Role Key Responsibilities<ul><li>Lead the site validation strategy across process, cleaning, packaging, and ongoing process and cleaning verification activities.</li><li>Own and maintain the Validation Master Plan, ensuring timely execution and inspection readiness.</li><li>Establish, monitor, and improve validation performance metrics to support compliance and operational excellence.</li><li>Provide technical leadership for validation risk assessments, investigations, and complex validation challenges.</li><li>Partner with Engineering, Quality, Analytical Science & Technology, and IT to define the interfaces to equipment qualification / utilities qualification, system qualification, analytical method validation.</li><li>Support product launches and technical transfers by defining robust validation approaches and delivering required data.</li><li>Represent the site during audits, inspections, and validation governance activities while maintaining compliance standards.</li></ul>Essential Requirements<ul><li>Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or a related scientific discipline.</li><li>8 years of experience in manufacturing / manufacturing science and technology / technical development / quality in oral solid dosage pharmaceutical manufacturing.</li><li>5 years of experience executing process validation, including experience leading and managing validation projects.</li><li>Proven expertise leading process validation, cleaning validation, and ongoing process verification programs.</li><li>Strong knowledge of quality systems applied statistics, and global regulatory requirements.</li><li>Demonstrated success managing complex cross-functional projects and authoring technical validation documentation.</li></ul>Desirable Requirements<ul><li>PhD Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent. </li></ul>The salary for this position is expected to range between $126,000 and $234,000 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. To learn more about the culture, rewards and benefits we offer our people click here. #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: Learn about all the ways we'll help you thrive personally and professionally. Read our handbook (PDF 30 MB) 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.

Validation Lead

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Novartis Pharmaceuticals Corp. Jobs

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