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Job Description The primary responsibilities include, but are not limited to:<ul><li>General secretarial/clerical tasks including scheduling of complex meetings, management of calendar, filing of monthly expense reports for multiple therapeutic area regulatory liaisons.</li><li>General support of the Rahway-based staff, as needed, with ordering supplies, ad-hoc meeting support, good office management practices, etc. to ensure a well-functioning environment.</li><li>Scheduling domestic and complex, multi-leg and international travel, including Demonstrated processing of Visas/Passports.</li><li>Supporting Team Sites and other communication channels.</li><li>Coordination and collaboration with other team members across the organization, including coordination of special projects within the division/area.</li></ul> Education: <ul><li>High School Diploma required.</li><li>Advanced education or certifications such as (e.g. Certified) Administrative Professional, Project Management Professional Certification, Professional in Human Resources Certification) preferred.</li></ul> Required Experience & Skills <ul><li>Minimum of (10) years Administrative Assistant experience</li><li>Minimum of (5) years Executive Administrative experience supporting senior executives (Sr. Director, Executive Director, VP or above)</li><li>Outstanding attention to detail, critical thinking, and creative problem-solving skills.</li><li>Proven ability to rapidly understand outcomes, priorities and project principles and use independent judgment to coordinate, prioritize, and deliver on multiple simultaneous assignments</li><li>Excellent interpersonal, listening and communication skills, verbal and written.</li><li>Demonstrated ability to effectively interact with executives and internal/external clients both on-site and remotely.</li><li>Demonstrated ability to rapidly learn new skills, develop a nuanced understanding of critical stakeholders and priorities and to apply situational leadership; continuous improvement mindset</li><li>Proactive, approachable, customer-focused attitude. High personal integrity, credibility and energy</li><li>Advanced computer skills using MS Office Suite (Outlook, Word, Excel, PowerPoint etc.)</li></ul>Preferred Experience & Skills<ul><li>SAP experience processing: Expense Reports; Purchase Orders and Payment Requests;</li><li>Vendor Add Forms, as well as the capability to run reports within SAP</li><li>Experience with event planning and coordination</li><li>Experience with financial and budget tasks</li></ul> #MSJR 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". 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: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Required Skills: Communication, Cross-Team Collaboration, Data Entry, Event Planning, File Management, Financial Budgeting, International Travels, Leadership, Management Process, Microsoft Office, Office Administration, Office Applications, Prioritization, Process Improvements, Project Management, Scheduling, Stakeholder Engagement, Task Coordination, Travel Scheduling, Vendor Management, Visa Applications Preferred Skills: Job Posting End Date: 08/11/2025 *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:R360842

public

Sr. Associate, Administrative Services

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Senior Instrumentation Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing support. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates, and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required. Under the supervision of the Maintenance Manager and/or Lead, the selected candidate will utilize strong knowledge of precision measurement science (Metrology), mathematics, physics, and electronics to test, calibrate, troubleshoot, maintain and repair instrumentation/controls. All duties must be performed in compliance with established company, department, and safety policies and procedures within GXP-regulated and non-GXP facilities. The incumbent will execute daily work assignments and ensure timely completion of all scheduled and unscheduled events for instrumentation systems controls. The individual in this role will collect, compile, measure, summarize, and record data obtained during scheduled calibration and/or unscheduled work requests. This position will work in conjunction with Facilities, Engineering, Validation, Manufacturing, and Quality Departments to help the company and all of its personnel to reach their goals in providing a safe, clean, and efficient environment. Shift: 12-hour, 2-2-3 Day Shift Responsible for supporting: <ul><li>Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns) </li><li>Support Equipment (e.g. washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation) </li><li>Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation System (BAS)) </li><li>Clean-In-Place (CIP) Systems </li><li>Maintenance Equipment (e.g. tools and calibration equipment) </li><li>Support to Digital Platforms (e.g. SAP, ProCal, Brady)</li><li>Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems</li><li>Contributes to the performance and results of the department</li><li>Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units</li><li>Decisions are guided by policies, procedures, and business plan; receives guidance from manager</li><li>Knowledge of instrumentation, PLCs and electronic and pneumatic loop control systems</li><li>Perform routine calibrations of instrumentation.</li><li>Perform maintenance, troubleshooting, repair, design, installation, and configuration of equipment, instrumentation and control systems</li><li>Perform out of tolerance reports</li><li>Maintains calibration standards</li><li>Identify Out of Tolerance" conditions and perform corrective actions to return the device to within specification.</li><li>Participate with investigating and documenting the potential impact that the Out of Tolerance" condition may have had on the instrumentation and process.</li></ul>Must be flexible to perform all the following functions and other tasks, as needed: <ul><li>Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves, and CIP skids.</li><li>Testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.</li><li>Support updates to preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required.</li><li>Assists with execution of automation, validation, and additional testing, as required</li><li>Responsible for written documentation of activities</li><li>Completes preventative maintenance and calibration work orders</li><li>Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures</li><li>Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines </li><li>Effective maintenance, troubleshooting, and problem-solving skills required</li><li>Ability to manage multiple priorities and advance several tasks in parallel</li><li>Demonstrated instrumentation aptitude</li><li>Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation.</li><li>Ability to read P&ID's, electrical drawings, blueprints, etc.</li><li>Routine shift will be a 12-hour, 2-2-3 Day Shift schedule, including holidays and alternating weekends. Required to support an on-call schedule for off-day and weekends .</li><li> Must possess good organizational, communication and time management skills, with a strong attention to detail, be able to follow Standard Operating Procedures, Calibration Procedures, and work instructions. </li><li> Must be self-motivated, able to work both independently and as part of a team with strict adherence to all environmental, health and safety policies and procedures. </li><li> Candidates must have good comprehension and work experience using calibration principals, along with basic computer skills. </li><li> Experience in calibration and process control experience involving but not limited to Conductivity, Flow, Level, pH, Pressure, Temperature, Speed and Weight, RH, Gas Concentrations, Electrical, etc. </li></ul>Required Education, and Experience <ul><li>High School Diploma/GED or higher and four (4) years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical and mechanical</li><li> Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations </li></ul> Preferred Experience and Skills: <ul><li>Associate Degree in Industrial Systems, Mechanical, Electronics, Electrical or Instrumentation</li><li>Experience working in a clean room or GMP/regulated manufacturing environment</li><li>Operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field</li><li>Experience with GMP compliant calibration and/or maintenance database systems.</li><li>Knowledge of SAP and DeltaV and Procal</li><li>Extensive calibration/instrumentation experience</li><li>ASQ CCT Certification and or ISA CCST Certification (Any Level ) </li></ul> Physical Requirements: <ul><li>Willing and able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level.</li><li>Walking, bending, crawling and stooping are required. . </li><li>Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc. </li><li>Position requires clean room gowning during performance of job duties</li></ul> Skills: <ul><li>Effective communication both written and oral</li><li>Effective Calibration/Instrumentation Skills</li><li> Effective maintenance, troubleshooting, and problem-solving skills </li><li>Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.</li><li>Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems.</li><li> Available for On-Call" work rotation (during off-hours) and weekend overtime, as needed. </li></ul> #MSJR 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". 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): Required Skills: Calibration of Equipment, Computerized Maintenance Management Systems (CMMS), Equipment Maintenance, Facility Maintenance, Hydraulic Maintenance, Mechanical Maintenance, Troubleshooting Preferred Skills: Job Posting End Date: 08/22/2025 *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:R360264

Sr. Tech, Operations

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Associate Specialist is an entry-level, or early career, individual contributor. ACCOUNTABILITY Under the supervision of a Senior Specialist or Associate Director, this individual is responsible to provide day-to-day equipment and facility engineering support for their assigned area. Actively ensures compliance to current Good Manufacturing Practices, Safety and Environmental regulations while achieving operating cost goals. Assigned area(s) may include: vaccine bulk manufacturing, formulation/filling, lyophilization, packaging, and/or support utilities including power, HVAC, steam, WFI, and controlled temperature units. Assigned tasks may include:<ul><li>Supporting and monitoring of equipment performance</li><li>Equipment maintenance</li><li>Developing equipment and facility improvement plans</li><li>Troubleshooting process equipment to ensure reliable, compliant and efficient operations.</li><li>Execution of equipment lock-out tag-out (LOTO)</li></ul> DUTIES <ul><li>Provides day-to-day shop floor equipment, instrumentation, robotic & utilities engineering support to manufacturing operations.</li><li>Ensures adequate spare parts inventory.</li><li>Provides technical assistance in the maintenance planning process.</li><li>Optimizes and coordinates scheduling of preventative, predictive & corrective maintenance to improve equipment reliability.</li><li>Assists in the facilitation of maintenance work, including leading JSA/LOTO execution, directing mechanic labor, and identifying spare parts.</li><li>Develops and maintains metrics used to run the business. Communicates and presents metrics/reports regularly.</li><li>Interacts with hourly, salaried and contract employees in routine matters, troubleshooting equipment and automation systems.</li><li>Provides supervisory coverage when required.</li><li>Promotes open communications and team work.</li><li>Maintains a high level of technical knowledge and may coordinate safety, current Good Manufacturing Practices, and environmental compliance programs.</li><li>Actively supports productivity improvement program and resolution of deviation events. Participates in root cause investigations. </li><li>Evaluates, develops and improves business processes and develops technical rationale for system improvements.</li><li>Assists with development of Qualification, SOP and Preventative Maintenance documentation and provides reports, data andinformation to support on-going operations.</li><li>Assists with project execution from concept to qualification, which may involve facilities, utilities, equipment, automation, or process related upgrades based on project requirements and site procedures.</li><li>Summarizes project progress, delays, or improvement opportunities. Frequently communicates with immediate supervisor about status of projects or assignments.</li><li>Develops strong relationships with site operations to ensure consensus on operational and regulatory compliance issues.</li><li>Assist in audits, regulatory inspections and training in the area of responsibility.</li></ul> QUALIFICATIONS : Essential:<ul><li>B.S. Engineering, Science, or 4 Year Engineering Technology Degree.</li><li>Zero (0) to three (3) years of relevant work experience</li><li>Demonstrated ability to work independently and as part of a team.</li><li>Good analytical abilities, organizational skills, written and verbal communication skills.</li></ul>Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. 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 $77,700.00 - $122,300.00 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: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 3rd - Night Valid Driving License: No Hazardous Material(s): n/a Required Skills: Business Processes, Business Processes, Business Process Modeling, cGMP Compliance, Change Management, Corrective Maintenance, Data Analysis, Energy Saving Programs, Engineering Standards, Engineering Technology, Environmental Regulations, Failure Mode and Effects Analysis FMEA, Intrapersonal Communication, Lean Six Sigma Continuous Improvement, Maintenance Planning, Maintenance Planning Software, Maintenance Troubleshooting, Management Process, Manufacturing Quality Control, Process Design, Productivity Improvements, Project Estimations, Regulatory Compliance, Regulatory Inspections, Root Cause Analysis (RCA) {+ 4 more} Preferred Skills: Job Posting End Date: 08/11/2025 *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:R356683

Assoc. Spclst, Engineering

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products. The Sr. Specialist, Calibration Engineer is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham Bulk Facility. The successful candidate will provide calibration, instrumentation and controls support for Clean Utilities, Purification, Sterile Supply, Alum and Fermentation suites. This position will focus on maintaining the calibration program, including implementation of new instruments for calibration, investigation into atypical instrument events and continuous improvement by through analysis of instrument performance. General Profile:<ul><li>Individual contributor role working with calibration teams across the site with limited oversight to focus instrument performance and minimize downtime.</li><li>Initiate and complete SOP revisions.</li><li>Lead 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.</li><li>Review and approve out of tolerance (OOT) records and ensure quality notifications follow when required.</li><li>Facilitate scheduling of calibration activities with the Planning and Scheduling team.</li><li>Anticipates and interprets client and/or customer needs to identify solutions.</li><li>Works as a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners.</li><li>Initiate, Review or Approve changes in the Calibration system (ProCal).</li><li>Manage approved vendors for calibrations not performed by site personnel.</li><li>Participate in site shutdown meetings, ensuring calibration activities are tracked to completion.</li><li>Participate in RBAM updates for the whole site.</li><li>Establish Metrics to monitor performance of instruments and be able to identify trends.</li><li>Work with project personnel to ensure appropriate instrument turnover to site.</li><li>Expand knowledge into other systems, capable of managing change in the pursuit of continuous improvement.</li><li>Lead projects for a B150 Engineering/Maintenance.</li><li>SME on Instrumentation and control loops, i.e., 4 to 20 mA, HART, ASI and Profibus communication</li><li>Able to train individuals in the execution of calibration work for the site.</li><li>Capable technical writing skills, able to document assessments used to justify changes to instrumentation.</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.</li></ul>This position is a 1st shift position with the potential for infrequent off shift work as needed to support business results. This position is expected to work as an independent member of an integrated team focused on achieving the team's objectives, vision, and goals. Required Education, Experience and Skills: <ul><li>Bachelor's Degree or higher in Engineering, Science or related field.</li><li>4 years of experience in field calibration, metrology or equipment reliability.</li><li>Project Management experience</li><li>Familiarity of regulatory requirements in accordance with GMP manufacturing operations</li><li>Good oral and written communication skills</li><li>Experience with GMP compliant calibration databases</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>Technical writing and deviation investigation experience</li><li>Strong</li><li>Experience in problem solving and troubleshooting.</li></ul> Preferred Education, Experience and Skills: <ul><li>Project Management experience</li><li>Familiarity of World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.)</li><li>ProCal or similar digital calibration system experience.</li><li>Allen Bradley PLC and Delta V controls experience</li><li>VFD Troubleshooting</li><li>Familiar with data analysis tools to analyze large amounts of data (ex. PowerApps, Spotfire)</li><li>cGMP experience in a sterile, bulk or finished pharmaceutical environment.</li><li>Mechanical functionality and reliability knowledge (asset management)</li><li>Certified Maintenance Professional (CMRP, CRL, etc.)</li></ul>Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time. VETJOBS 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 $104,200.00 - $163,900.00 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Analytical Method Development, Analytical Method Development, Analytical Thinking, Animal Vaccination, Calibration Management Software, Calibration Procedures, Deviation Management, Facility Design, GMP Compliance, Interpersonal Relationships, Maintenance Management, Manufacturing Process Validation, Personal Initiative, Process Optimization, Product Testing, Project Management, Project Team Leadership, Regulatory Requirements, Root Cause Analysis (RCA), Self-Management, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Technical Problem-Solving, Veterinary Medicine, Veterinary Pathology {+ 1 more} Preferred Skills: Job Posting End Date: 08/22/2025 *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:R359861

Calibration Engineer Sr. Specialist

Job Description The Center for Packaging & Device Analytics (CPDA), within our Manufacturing Division, has responsibility for physical analytical & functional material science for packaging production support and commercialization of new product packaging and combination-product/medical devices. This Center of Excellence supports the entire global-human-health portfolio and closely partners with various Packaging Technology engineering groups, global packaging sites, and other analytical groups. The CPDA is located at our West Point, PA facility. We own and administer our company's internal packaging technology laboratories, which we use to conduct non-compendial qualification/ characterization of new components & configurations, design & execute testing to verify device design/functionality, and advance significant investigations of packaging performance through applied science. The group also contributes to new technology risk assessment, packaging control strategy, packaging line qualification & quality risk management, authoring new filing sections (packaging specs and methods), improving incoming/in-process/on-line physical testing at packaging sites, and, serving as the company experts on primary packaging barrier modeling & configuration design, container closure integrity (CCI) and physical measurement techniques that support packaging. The CPDA is seeking a Scientist who as an individual contributor, will apply engineering science, materials science and related physical-chemistry, to support late-stage product development and global manufacturing, with a particular focus on supporting our bio-sterile and medical device/combination-product portfolio. Projects will involve hands-on laboratory experimentation with standard primary packaging assessments [e.g. moisture ingress, UV transmission], participation in the development, validation and execution of mechanical testing methods [e.g. uniaxial tension, torsional testing], and/or other general materials characterization. The ideal candidate will be skillful in problem solving, delivering impact through hands-on physical applied science, and communicating [both verbal and written] for accurate, complete and clear laboratory notebooks and technical reports. Required Education, Experience, and Skills: Education minimum requirement: B.S. in chemical or mechanical engineering or related field. Required Experience Qualifications: 2 years in an industrial (hands-on) laboratory role. Preferred Experience/Qualifications: Experience and proficiency in (1) development and validation of functional/mechanical test methods for medical combination products/devices (2) packaging characterization (3) design verification testing. Software : MS office (Word, excel), ELN. *Note*: &bull; 100% onsite role, lab-based. Work will primarily be 1st shift; however, project support may occasionally (5%) require flexibility to work some hours during 2nd shift. 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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Adaptability, Analytical Instrumentation, Analytical Method Development, Analytical Problem Solving, Analytical Testing, Applied Engineering, Communication, Detail-Oriented, Laboratory Documentation, Laboratory Safety, Materials Engineering, Materials Science, Mechanical Testing, Method Validation, Microsoft Office Preferred Skills: Job Posting End Date: 08/22/2025 *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:R359237

Packaging & Device Scientist

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Maintenance and Instrumentation Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing support. Support updates to standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates, and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required. Under the supervision of the Maintenance Manager, the selected candidate will utilize strong knowledge of precision measurement science (Metrology), mathematics, physics, and electronics to test, calibrate, troubleshoot, maintain and repair instrumentation/controls. All duties must be performed in compliance with established company, department, and safety policies and procedures within GXP-regulated and non-GXP facilities. The incumbent will execute daily work assignments and ensure timely completion of all scheduled and unscheduled events for instrumentation systems controls. The individual in this role will collect, compile, measure, summarize, and record data obtained during scheduled calibration and/or unscheduled work requests. This position will work in conjunction with Facilities, Engineering, Validation, Manufacturing, and Quality Control Departments to help the company and all of its personnel to reach their goals in providing a safe, clean, and efficient environment. Responsible for supporting: <ul><li>Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns) </li><li>Support Equipment (e.g. washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation) </li><li>Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation System (BAS)) </li><li>Clean-In-Place (CIP) Systems </li><li>Maintenance Equipment (e.g. tools and calibration equipment) </li><li>Support to Digital Platforms (e.g. SAP, ProCal, Brady)</li><li>Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems</li><li>Contributes to the performance and results of the department</li><li>Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units</li><li>Assisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes</li><li>Decisions are guided by policies, procedures, and business plan; receives guidance from manager</li><li>Strong knowledge of instrumentation, PLCs and electronic and pneumatic loop control systems within the following disciplines: Conductivity, Low Frequency Electromagnetic Flow, Level, Mechanical, Optical, pH, Pressure, Temperature, Time, Speed and Weight.</li><li>Perform routine calibrations of instrumentation. Perform maintenance, troubleshooting, repair, design, installation, and configuration of equipment, instrumentation and control systems.</li><li>Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are carried out in accordance with established safety, GMP, and calibration/maintenance procedures.</li><li>Assist in the identification and selection of replacement equipment, software, and instrumentation for existing systems and equipment.</li><li>Perform out of tolerance reports, which may include doing reverse traceability. Calibration Drift analysis and executing changes to improve calibration program.</li><li>Propose calibration equipment upgrade requirement when needed in order to be in compliance and up to date with calibration orders.</li><li>Review's vendor calibration certificates.</li><li>Maintains calibration standards</li><li>Redline drawings, engineering documentation and other technical specifications</li><li>Identify Out of Tolerance" conditions and perform corrective actions to return the device to within specification. Participate with investigating and documenting the potential impact that the Out of Tolerance" condition may have had on the instrumentation and process.</li><li>Develop and/or revise calibration procedures and job plans while looking for ways to improve how calibrations and troubleshooting is performed in an attempt to make those practices more efficient.</li><li>Provide support and training to peers to improve their abilities and increase their technical knowledge</li><li>Assists supervision with the assigning, scheduling and prioritization of work order requests using maintenance management systems.</li></ul>Must be flexible to perform all the following functions and other tasks, as needed: <ul><li>Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves, and CIP skids.</li><li>Testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.</li><li>Support updates of standard operating procedures (SOPs), preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required.</li><li>Identify spare parts for preventive maintenance plans.</li><li>Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems</li><li>Assists with execution of automation, validation, and additional testing, as required</li><li>Responsible for written documentation of activities</li><li>Completes preventative maintenance and calibration work orders, resolves deviations, and evaluates equipment performance for efficient operation.</li><li>Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures</li><li>Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines</li><li>Effective maintenance, troubleshooting, and problem-solving skills required</li><li>Ability to manage multiple priorities and advance several tasks in parallel</li><li>Demonstrated instrumentation aptitude</li><li>Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation.</li><li>Ability to read P&ID's, electrical drawings, blueprints, etc.</li><li>Routine shift will be 2-2-3, 12-hour day shift schedule, including holidays and alternating weekends. Successful candidate will be required to work an 8-hour weekday schedule until shift is required.</li><li>Must possess good organizational, communication and time management skills, with a strong attention to detail, be able to follow Standard Operating Procedures, Calibration Procedures, and work instructions. </li><li>Must be self-motivated, able to work both independently and as part of a team with strict adherence to all environmental, health and safety policies and procedures. </li><li>Candidates must have good comprehension and work experience using calibration principals, along with basic computer skills.</li><li>Broad spectrum of calibration and process control experience involving but not limited to Conductivity, Flow, Level, pH, Pressure, Temperature, Speed and Weight, RH, Gas Concentrations, Electrical, etc. </li><li>"Self-starter" attitude and ability to learn and understand new equipment or instrumentation.</li></ul>Required Education, and Experience <ul><li>High School Diploma/GED or higher and six (6) years of plant maintenance or equivalent Military experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems)</li></ul><ul><li>Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations</li></ul>Preferred Experience and Skills:<ul><li>Associate Degree in Industrial Systems, Mechanical, Electronics, Electrical or Instrumentation</li><li>Experience working in a clean room or GMP/regulated manufacturing environment</li><li>Operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field</li><li>Experience with GMP compliant calibration and/or maintenance database systems.</li><li>Knowledge of SAP and DeltaV and Procal</li><li>Extensive calibration/instrumentation experience</li></ul><ul><li>ASQ CCT Certification and or ISA CCST Certification (Any Level)</li></ul>Physical Requirements<ul><li>Willing and able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level.</li><li>Walking, bending, crawling and stooping are required. . </li></ul><ul><li>Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc. </li><li>Position requires clean room gowning during performance of job duties</li></ul> Skills: <ul><li>Effective communication both written and oral</li><li>Effective Calibration/Instrumentation Skills</li><li>Effective maintenance, troubleshooting, and problem-solving skills</li><li>Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.</li><li>Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems.</li><li>Must demonstrate adept leadership skills.</li><li>Strong planning, scheduling, and time management skills.</li><li>Available for On-Call" work rotation (during off-hours) and weekend overtime, as needed.</li></ul>#MSJR VETJOBS 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". 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): Required Skills: Building Automation Systems, Calibration Management Software, Calibration Procedures, Equipment Maintenance, GMP Compliance, Instrument Calibrations, Lockout Tagout, Mechanical Troubleshooting, Metrology, Programmable Logic Controller (PLC) Preferred Skills: Job Posting End Date: 08/22/2025 *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:R360967

Lead Maintenance and Instrumentation Technician

Job Description We're seeking an exceptional leader to join our team as an Associate Director, Engineering, Maintenance & Utilities. As a leader in our team, you'll have the opportunity to make a significant impact on our operations and drive business results. As a member of the Engineering, Maintenance, & Utility Department, the HEPA Certification Associate Director is accountable for the management of the HEPA certification personnel and program supporting our Manufacturing Division at the West Point, PA site. This group is responsible for improving asset reliability and manufacturing capacity by providing technical support in the field on engineering resolution of manufacturing mechanical or automation problems, processes incompliance with GMP, safety, and environmental regulations. ACCOUNTABILITY <ul><li>Ensure that area objectives are achieved while reliably supplying quality product at a competitive cost consistent with our company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal employment opportunity, finances, labor, employee, environment and safety;</li><li>Tactical and strategic Area management, including collaboration with indirect staff;</li><li>Promote the behaviors and principles that drive continuous improvement.</li></ul> DUTIES <ul><li>Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First Time culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or need.</li><li>Supply - Lead Area daily walkthrough. Exercise independent judgment and decision making to ensure quality product is reliably produced while managing cost. Responsible for Area supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).</li><li>Continuous Improvement - Accountable for developing a company Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Area. Develop strategic initiatives related to the manufacturing process, equipment and human resources in support of long range operating plans. Report Area monthly metrics and any action plans to address gaps to the IPT Leadership team. Identify, prioritize, and champion improvement projects to improve process efficiency, cycle time, and yield, reduce process variability, and eliminate waste.</li><li>Financial Stewardship - Responsible for development and management of the Area operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing cost. Ensure members of the Area have business acumen and understand how they may impact business finances.</li><li>People Management - Responsible for creating and sustaining a highly engaged workforce through utilization of our companys Leadership Behaviors and Inclusion. Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect staff. Support IPT Talent Management.</li></ul>In accordance with Policy 82 - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. QUALIFICATIONS : Essential:<ul><li>Required: Bachelor's Degree in Business Administration, Science, Engineering or another technical field</li><li>Minimum (6) years' experience in more than one functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain.</li><li>Experience with HEPA certification</li><li>Concurrently, minimum (2) years of line experience, with responsibility for direct reports.</li></ul>Preferred:<ul><li>Minimum of (2) years' experience in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.)</li><li>Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing</li><li>Demonstrated ability to create an engaged workforce using Inclusion as the How</li><li>Demonstrated experience of interacting with site, divisional or regulatory audits</li><li>Demonstrated success with Talent Management</li><li>Working Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management). Computerized Management Maintenance Systems SAP), and CMRP certification desired.</li></ul>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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Good Manufacturing Practices (GMP), Lean Six Sigma (LSS), Maintenance Management, Mechatronics, Particulate Filters, People Leadership, Strategic Initiative Preferred Skills: Job Posting End Date: 08/21/2025 *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:R360645

Assoc. Dir, Engineering HEPA Certifications

Job Description Working closely with Senior Packaging Technicians, work within a team environment to execute clinical packaging and labeling activities, including material, room and equipment staging, execution and documentation of operations, and room clearance and cleaning. Perform visual inspection of rooms and equipment post-cleaning. Provide hands-on training for new employees. Support additional operational activities in support of sampling and material transfer. Performs all tasks related to clinical label printing production. Maintain training and compliance with site safety and quality requirements. This role is part of a shift, with specific requirements for start and stop times and requires onsite presence five days a week. General Responsibilities: <ul><li>Maintain cGMP and safety training to site requirements </li><li>Follow cGMP, Standard Operating Procedure (SOP) and safety requirements in all activities </li><li>Report potential quality events, non-conformance to GMPs/SOPs when observed </li><li>Ensure all paperwork is properly executed using Good Documentation Practices </li><li>Occasional overtime and weekend work may be requested </li><li>Interact with employees within own department as well as frequent interactions with employees from other groups/departments </li></ul> Warehouse-specific Responsibilities: <ul><li>Perform incoming material receipt, clinical site drug returns and sample management</li><li>Receive, inspect and store all warehouse inventory</li><li>Execute sample collection activities</li><li>Perform inventory functions such as weekly replenishment, posting of Excess & Obsolete inventory and min/max changes</li><li>Coordinate and execute discard process for, but not limited to, expired and non-available inventory</li><li>Process order management and material staging in support of packaging/labeling work centers</li><li>Emergency cold vault coverage, when needed</li><li>Perform regular cycle counts, ensuring system inventory accuracy</li><li>Manages shipping activities, freight and logistics functions (pick, pack, label, schedule, ship)</li><li>May be assigned to coordinate and/or prioritize warehouse activities</li></ul> Documentation: <ul><li>Creation of Packaging documents according to SOPs.</li><li>Ensures correct documentation of transactions within SAP.</li><li>Documentation according to Good Documentation Practice (GDP) Guideline.</li><li>Check of correct content of written Good Manufacturing Practice (GMP) documents.</li></ul> Education: <ul><li>High School Diploma or equivalent required</li></ul> Experience & Skills: <ul><li>Growth mindset</li><li>Team player</li><li>Desire to learn packaging operations</li><li>Excellent interpersonal and communication skills.</li></ul> Requirements: <ul><li>Ability to repetitively lift, carry, push and pull up to 50 lbs. required for Packaging and Warehouse roles </li><li>Ability to quickly learn new systems required </li><li>Demonstrate competency and in-depth knowledge of all processes, methods and procedures related to GMP environment and area-specific tasks </li></ul> #MSJR #GCScareer #eligibleforERP 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". 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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Accountability, Freight Shipping, GMP Compliance, Logistics Management, Manufacturing, New Hire Training, Obsolete Inventory, Packaging, Packaging Processes, Proper Documentation, Safety Training Programs, Standard Operating Procedure (SOP), Visual Inspections, Warehouse Management Preferred Skills: Job Posting End Date: 08/14/2025 *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:R360964

Clinical Packaging Technician

Job Description The Director reports to the Executive Director of SMAR&D and will lead a team of approximately 10-15 analytical scientists in Rahway that works closely within multidisciplinary DSCS teams. This role has a wide responsibility for analytical method development and testing for chemical and biocatalytic synthetic processes, and / or a variety of formulations (e.g., oral, parenteral, and specialty dosage). The director should be well engaged with regulatory and industry trends to guide future activities for Analytical R&D and DSCS. The candidate will have experience in an innovative analytical/regulatory/GMP environment. The Director will effectively partner with the SMAR&D leadership team in order to identify and advance key departmental technical, strategic and cultural initiatives. The Director will identify, recruit, onboard and develop employees to their full potential. The candidate will establish a viable succession plan for key positions within SMAR&D (scientific and management pathways), including their own role. The position is responsible for disclosures prepared within the group to be used as the basis for external publications and filings. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management, as necessary. Maintaining an effective network internally, and across the external academic and regulatory community, is expected, as is as advancing a culture of scientific excellence, GMP and compliance mindset, and collaboration with various partners and stakeholders in development. Essential Knowledge, Duties & Responsibilities include:<ul><li>Analytical methodologies</li><li>Project management skills</li><li>Review and approval of data</li><li>Representation of the laboratory for internal and external audits</li><li>Team and staff development</li><li>Thorough working knowledge of GMPs, ICH, and relevant Health Authority regulatory guidelines</li></ul>Education: <ul><li>BS or MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development.</li><li>Ph.D. in chemistry or related science with 7 years of industrial experience with pharmaceutical drug substance and/or product development.</li></ul>Required Skills:<ul><li>Demonstrated ability in leading teams.</li><li>Track record of effective talent development</li><li>Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills</li><li>Ability to work in a team environment with cross-functional interactions is essential</li><li>Strength in delivering results on firm deadlines in support of drug development and commercial filing</li></ul>#AR&D 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Adaptability, Analytical Method Development, Biologics License Application (BLA), Business, Chromatographic Techniques, Decision Making, Dosage Forms, Innovation, Management Process, People Leadership, Process Analytical Technology (PAT), Professional Networking, Regulatory Compliance, Regulatory Submissions, Results-Oriented, Talent Development, Team Leadership, Technical Writing Preferred Skills: Job Posting End Date: 09/7/2025 *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:R360627

Director, Analytical R&D

Job Description Position Description The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production Supervisor manages a team of technicians for daily operations that support sterile supply, aseptic formulation, aseptic filling, and visual inspection. This role require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline. Accountability <ul><li>First line operations supervisor with a team of individual contributor production direct reports</li><li>Ensure that shift objectives are achieved while reliably supplying quality product at a competitive cost consistent with all applicable internal and external regulations for quality (GMP), safety, etc.</li><li>Attention to Detail: Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions.</li><li>Tactical and strategic shift management, including collaboration with indirect staff</li><li>Batch Adaptability: Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills.</li><li>Promote the behaviors and principles that drive continuous improvement </li></ul> Duties <ul><li>Coordinates and supervises the daily activities of individual contributors. Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors and develops plans to meet short-term objectives.</li><li>Identifies and resolves standard day to day quality, technical, and operational problems within own unit. Makes decisions - guided by policies and standard operating procedures - that impact the efficiency and effectiveness of own unit. Receives guidance and oversight from the Operations Director.</li><li>Works within budgetary/financial objectives set by Director </li><li>Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or need. </li><li>Supply - Exercise judgement and decision making to ensure quality product is reliably produced while managing cost. Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).</li><li>Continuous Improvement - Accountable for developing a our Company Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s). Develop strategic initiatives related to the manufacturing process, equipment and human resources in support of long range operating plans. Report Shift(s) monthly metrics and any action plans to address gaps to Management. Identify, prioritize and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability and eliminate waste.</li><li>People Management - Responsible for creating and sustaining a highly engaged workforce through utilization of our Company Leadership Behaviors and Inclusion. Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect staff. Support Talent Management. </li><li>Position may require work outside of routine hours (e.g. nights / weekends), depending on business needs.</li></ul> Core Skillsets <ul><li>Aseptic experience: Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring.</li><li>Ability to develop and lead others.</li><li>Ability to be flexible and understand risk.</li><li>Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery of supplies.</li><li>Continuous improvement</li><li>Conflict resolution</li><li>Leadership style - adaptive; high performance coaching; servant leader</li><li>Compliance mindset to safety, environmental, and quality regulations</li></ul> Position Qualifications : Education Minimum Requirement: Bachelor's degree in business administration, Science, Engineering or another technical field with a minimum of 4 years of experience, or at least 7 years' experience in pharmaceutical manufacturing or processing with HS diploma. Required Experience and Skills: <ul><li>Minimum (4) years' experience in a functional area, such as operations Management, Quality, Technical Operations, Technology, Engineering or Maintenance.</li><li>Minimum (2) years' experience in aseptic/sterile drug product manufacturing or processing</li></ul>Preferred Experience and Skills:<ul><li>Minimum (2) years' direct supervisory experience.</li><li>Demonstrated knowledge of Lean</li><li>Demonstrated experience of interacting with site, divisional or regulatory audits</li></ul>#MSJR #eligibleforerp 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: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 2nd - Evening Valid Driving License: No Hazardous Material(s): potent processing Required Skills: Communication, Continual Improvement Process, Cost Management, Driving Continuous Improvement, Engineering Standards, Equipment Maintenance, Estimation and Planning, GMP Compliance, Management Process, Manufacturing Processes, Manufacturing Process Improvements, Pharmaceutical Manufacturing, Process Improvements, Product Formulation, Quality Management Systems (QMS), Regulatory Compliance, Regulatory Requirements, Safety Standards, Standard Operating Procedure (SOP), Sterile Manufacturing, Strategic Initiative, Strategic Thinking Preferred Skills: People Leadership Job Posting End Date: 08/22/2025 *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:R360764

Sterile Production Supervisor (2nd shift)

Job Description Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Position Description This is a night shift position, 12.5 hour (6:00PM - 6:30 AM) rotation (2-2-3). The VMF (Vaccine Manufacturing Facility) Associate Production Technician is an excellent entry-level opportunity for recent university graduates or experienced individuals that are interested in working in vaccine production and manufacturing operations. The individual in this position will support the vaccine manufacturing process through hands on processing activities. Key responsibilities for the Associate Production Technician include the execution of aseptic processing requirements, adherence to GMP (Good Manufacturing Practices), and working in a self-directed team environment to accomplish shift and departmental goals. Responsibilities include, but are not limited to:<ul><li>Works collaboratively with all operations and support personnel, performing manual and automated processing of vaccine manufacturing equipment, performing general troubleshooting tasks, and supporting functions necessary for the production of vaccines.</li><li>Executes all documentation and clerical functions necessary for proper accountability and traceability of product.</li><li>Maintains, inventories, and transports all required processing equipment, materials, supplies and products needed to support manufacturing. </li><li>Operates various computer-controlled process support/process equipment (i.e. washer, autoclave, vial filler, lyophilizer, capping/inspect machines, etc.).</li><li>Assists in troubleshooting of equipment.</li><li>Performs housekeeping in all work areas. Executes facility sanitization and decontamination according to approved procedures.</li><li>Completes in-process testing and inspections supporting the vaccine manufacturing, validation, and development processes as required.</li><li>Identifies and addresses compliance, environmental, safety, and process deviations as appropriate and escalates to appropriate personnel.</li><li>Maintains, cleans and prepares equipment used in vaccine manufacturing process.</li><li>Schedules and performs environmental monitoring during processing and records results in the computerized database system. Provides timely delivery of samples and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.</li><li>Attends and actively participates in safety & housekeeping walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.</li><li>Serves on safety, quality and other committees as required.</li></ul>Education Minimum Requirement: <ul><li>A minimum High School Diploma or equivalent is required for this position.</li></ul>Required Experience and Skills: <ul><li>Must be willing to work 12-hour night shift (6:00PM to 630AM) on a rotating 2-2-3 schedule. Note that this schedule does include working alternating weekends and holidays</li><li>Must be able to successfully pass Aseptic gowning qualification. Aseptic gowning requires that all skin and hair be covered through wearing the following: Beard/moustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves and boots.</li><li>Must be willing and able to lift 50 lbs.</li><li>Must be willing to be vaccinated/blood tested for titer for products manufactured within the facility if needed.</li><li>Must be willing to work various shifts</li><li>Must be able to demonstrate basic computer literacy (internet browsers, e-mail, word processing).</li></ul>Preferred Experience and Skills:<ul><li>BioWorks Certificate (working in an FDA regulated industry).</li></ul>#MSJR 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". 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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 3rd - Night Valid Driving License: No Hazardous Material(s): N/A Required Skills: Chemical Plant Operations, Computer Literacy, Environmental Controls, Equipment Maintenance, Good Manufacturing Practices (GMP), Maintenance Processes, Manufacturing Operations, Operations Support, Pharmaceutical Production, Pharmaceutical Quality Assurance, Production Scheduling, Safety, Health, Environment and Quality (SHEQ), Safety Procedures, Shift Work, TB Screening, Technology Qualification, Troubleshooting, Union Experience Preferred Skills: Job Posting End Date: 08/15/2025 *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:R360833

Assoc. Tech, Operations Night Shift

Job Description We have an exciting opportunity for a Senior Specialist to join the business support and project management team for a capital project start-up in Durham, North Carolina. The facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. This position requires the ability to work independently with minimal supervision, produce/complete various assignments requiring analytical ability, demonstrate independent judgment, creativity and problem-solving skills. This role also requires strong collaboration and communication skills to enable interfacing with both internal contacts (local site level) and external contacts (external customers, above site partners, vendors) to support these initiatives. The Senior Specialist must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. Position Description : The duties of the Senior Specialist, Operations include but are not limited to: <ul><li> Assist with facilitation of Project and site Tier meetings and help manage the site project portfolio. </li><li> Guide cross-functional teams to advance project goals. </li><li> Drive cross-functional problem-solving teams </li><li> Support shop floor activities </li><li> Implement changes, corrective/preventative, and improvement actions </li><li> Assist in developing project controls and metrics to display the overall health of the project. </li><li> Partner with Learning & Development to develop learning plans and training system. </li><li> Develop and implement plans in partnership with other internal departments and above site and external contacts on different projects and initiatives. </li><li> Communication skills must be effective to interact with internal/external customers to manage projects, assignments, and workflow. </li><li> The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best comprehend and resolve it at the root cause. </li></ul> Key Competencies: <ul><li> Critical thinking, problem solving and decision-making skills </li><li> Ability to see big picture and identify improvements aligned with business objectives. </li><li> Comprehension of program and project management fundamentals including indirect management skills. </li><li> Prioritization, planning, organizing and delegation skills. </li><li> Working with peers, management and both internal and external partners. </li><li> Conflict management </li><li> Customer focused </li><li> Self-directed </li><li> Communication with diverse audiences </li><li> Strategic end to end thinking </li></ul> Education Qualifications: <ul><li> Bachelor's degree in an Engineering or Science related field with at least five (5) years of experience in manufacturing/operations in a regulated industry OR </li><li> Master's degree in an Engineering or Science related field with at least three (3) years of experience in manufacturing/operations in a regulated industry. </li></ul> Required Experience: <ul><li> Experience with Project Management and/or indirect leadership </li><li> Successful completion of TB blood test and Chest X-ray are required </li></ul> Preferred Qualifications: <ul><li> Experience working in a pharmaceutical, biotech or vaccines manufacturing environment. </li><li> Lean Six Sigma Green Belt or Black Belt Certification </li><li> Experience with aseptic processing operations such as automated visual inspection, filling, and/or lyophilization. </li><li> MES, SAP, GLIMS, PI Vision </li><li> Experience authoring technical documents such as Standard Operating Procedures (SOPs) and change requests within a current Good Manufacturing Practices (cGMP) context </li></ul>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 $94,300.00 - $148,500.00 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 Required Skills: Accountability, Adaptability, Analytical Problem Solving, Applied Engineering, cGMP Compliance, Data Analysis, Decision Making, Inventory Management, Lean Six Sigma Continuous Improvement, Management Process, Manufacturing Technologies, Personal Initiative, Process Improvements, Process Optimization, Production Planning, Production Scheduling, Training and Development, Vaccine Manufacturing Preferred Skills: Job Posting End Date: 08/22/2025 *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:R360642

Sr. Spclst, Operations

Job Description The Incoming Material Deviation Management Specialist is responsible for providing engineering/technical support to the Deviation Management Team within Core Site Services organization at West Point, PA site. The specialist is responsible to support Incoming Material Integrated Product Technology area to remain operational, in compliance, continuously improve and innovate. The Specialist:<ul><li>Authors incident and investigation reports for deviations</li><li>Coordinates and completes Corrective Actions and Preventive Actions (CAPAs)</li><li>Authors and reviews Incident Trend Reports</li><li>Supports deviation reduction efforts</li><li>Supports, executes, and/or leads continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process. </li><li>Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.</li><li>Authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment.</li><li>Provides on-the-floor support for project implementation and studies, as required</li><li>Leads or participates in Quality Risk Assessments.</li><li>Supports regulatory inspections/audits as required</li><li>Supports team safety, environmental, and compliance objectives.</li><li>Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.</li><li>Collaborates effectively with Operations, Quality, Planning, project teams, and external vendors.</li></ul>Education Minimum Requirement: <ul><li>B.S. or B.A. in Engineering, Sciences, or related discipline</li></ul>Required Experience and Skills:<ul><li>Minimum two (2) years post-bachelor's degree experience in a regulated environment.</li><li>Experience in deviation management / project support and/or change control and/or bio-pharm equipment and/or equipment/process validation.</li><li>Highly developed communication, leadership and teamwork skills.</li><li>Ability to manage projects/work to schedule/deadlines.</li></ul>Preferred Experience and Skills:<ul><li>Experience in biologics, vaccine, or bulk sterile manufacturing facilities and equipment. </li><li>Deviation Management</li><li>Change Management</li><li>Project Management</li></ul>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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Adaptability, Adaptability, Applied Engineering, Change Control Management, Data Analysis, Equipment Troubleshooting, Global Manufacturing, Global Supply Chain, Good Manufacturing Practices (GMP), Healthcare Innovation, Lean Manufacturing, Manufacturing Processes, Personal Initiative, Process Optimization, Professional Integrity, Project Implementations, Project Management, Project Procurement Management, Quality Risk Assessment, Regulatory Inspections, Regulatory Project Management, Root Cause Analysis (RCA), Strategic Procurement, Technical Writing, Technology Transfer {+ 1 more} Preferred Skills: Job Posting End Date: 08/20/2025 *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:R360622

Specialist, Engineering

Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Under the general direction of the Quality Assurance Integrated Process Team (IPT) Associate Director, the Quality Assurance Senior Specialist is responsible for leading all quality assurance activities in support of the Integrated Process Teams (IPT) at the Wilson Site, Packaging Center of Excellence for North America. The responsibilities of the Quality Assurance Senior Specialist include, but are not limited to"<ul><li>oversight of batch record reviews (audits) for domestic, intermediate and finished product releases for domestic and/or international markets</li><li>defect resolution in packaging operations and control of material throughout the plant</li><li>plant investigations</li><li>data compilation/ support for internal/external audits and regulatory inspections</li><li>SOP development and review</li><li>other Quality Assurance related functions as required.</li></ul>The Quality Assurance Senior Specialist is the primary source of advice, guidance and input regarding quality issues for production personnel, divisional teams and inter-site customers. In addition, this person is responsible for ensuring packaging activities are completed in compliance with all regulatory requirements, cGMPs, and corporate requirements through the coaching and development of other QA team personnel. Additional responsibilities include but are not limited to:<ul><li>Quality Assurance functions for plant wide systems/processes to include direct line support to production areas, deviations, product release and defect resolution</li><li>Attends cross-functional team meetings to ensure alignment of priorities and escalation of obstacles</li><li>Quality Risk Management facilitation and expertise</li><li>Manages activities to implement productivity enhancements to streamline activities</li><li>Serves as final reviewer and Quality approver of deviation investigations. In this capacity the Sr. Spclst ensures investigations have identified true root cause and appropriate corrective/preventative actions to prevent recurrence. In addition, evaluates to ensure quality impact assessment is robust.</li><li>Ensures Quality Assurance and overall site compliance in accordance with company policy and applicable government regulations. Makes provisions to ensure job responsibilities of the Quality Assurance area are conducted in a timely and reliable manner to meet production supply demands.</li><li>Acts as a key regulatory compliance liaison to interface with domestic and international regulatory agencies during audits/inspections (CDER and CBER).</li><li>Ensures that Quality Assurance maintains the necessary human and capital resources to meet present and future needs and manages those resources to meet annual profit plan.</li><li>Ensures adequate Quality support / coverage during off-shift hours of operation</li></ul>Education Minimum Requirement:<ul><li>Bachelor's degree in a science discipline is required.</li></ul>Required Experience and Skills: <ul><li>Five (5)+ years of experience in a GMP pharmaceutical manufacturing facility either with direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.</li><li>Deep understanding of Root Cause Analysis methods and investigation techniques.</li><li>The candidate must possess highly developed written and oral communication, leadership and teamwork skills. </li><li>The candidate must also possess a high degree of problem-solving ability and have demonstrated ability to independently manage multiple high-level priority projects/workload, ensuring timely completion.</li></ul>Preferred Experience and Skills:<ul><li>Experience in Quality Assurance.</li><li>Experience working in a Pharmaceutical packaging facility. </li><li>Experience with regulatory inspections/audits (CDER and CBER).</li><li>In-depth knowledge of domestic and international regulatory requirements.</li><li>Experience designing and implementing lean business processes.</li><li>SAP and MES system experience.</li></ul>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 $104,200.00 - $163,900.00 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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Required Skills: Batch Record Review, Configuration Management (CM), Detail-Oriented, Deviation Investigations, Driving Continuous Improvement, IS Audit, Management Process, Manufacturing Process Validation, Packaging Research, Quality Assurance (QA), Quality Control Management, Quality Improvement Programs, Quality Systems Compliance, Regulatory Experience, Statistical Process Control (SPC), Teamwork, Technical Specification Writing, Training and Development Preferred Skills: Job Posting End Date: 08/21/2025 *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:R359933

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