Sr. Spclst, Quality

**Job Description** **Title: Senior Specialist,** Analytical Metrology & Validation **, Global Quality Large Molecule Analytical Science, Manufacturing Division** **Job Description** The Global Quality Large Molecule Analytical Science (GQLMAS) department of our Company's Manufacturing Division is seeking applicants for an Senior Specialist leading an analytical metrology and validation team at the West Point, PA facility.  The Analytical Metrology & Validation Senior Specialist will work as part of the Global Quality Large Molecule Analytical Science and drive a culture of quality and operational excellence across the GQLMAS West Point and North Wales (NW4) labs. The Senior Specialist role works with a team of metrology and equipment coordination specialists supporting the maintenance and qualification of analytical equipment and instrumentation within the GMP and non-GMP environment. The key responsibilities / tasks of this role will include: + Mentoring and coaching junior metrology and validation specialist; overseeing day to day assignments + Collaborate with scientific teams across Global Quality and external partner groups to drive compliance and operational excellence + Oversee the maintenance and qualification of laboratory equipment and maintain equipment / instrumentation lifecycle For both GMP and non-GMP environments + Support internal and external quality audits and maintain laboratory state of permanent inspection readiness + Evaluating our Manufacturing Division QMS and developing a plan to switch over SOPs and equipment. + Promote primarily the validation of computerized Analytical and or production systems as per System Development Life Cycle guidelines, updated CFR Data Integrity standards, and other regulatory guidelines. + Automation and IT of various computer systems related to analytical or process equipment. + Partnering with the business unit in the laboratories, various quality sponsored oversight, IT technical promotion, and various software and instrument vendors/manufacturers. + Performing any change control activities during the life cycle of a computerized system. + Decommission systems as part of the System Development Life Cycle (validation) guidance. + Participate in various data integrity and lab modernization activities. + Lead Validation initiatives /projects as applicable + Author / Review / Approve Metrology and Validation Documents The successful candidate must function both independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.  Strong communications skills and eagerness to adapt and learn are essential attributes.  As a member of our team, you will be joining scientific and technical problem solvers who are dedicated to creating the life-changing medicines of tomorrow. **Education Minimum Requirements** M.S. with 2-3 years, or B.S. with 5-7 years of experience. **Required Experience and Skills** + A strong team player with the ability to work both independently and cross- functionally to deliver on complex objectives + The ability to problem solve using effective communication, innovative solutions, and strong technical skillsets. + Desire and ability to learn new concepts outside of core expertise and training + Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills + Related industry experience with metrology and equipment maintenance and calibration. + Experience working within a GMP environment. + Understanding of GMP policies and procedures. + Ability to self-regulate and prioritize based on communications from management and various project teams (e.g. time management). + Ability to author and review/approve specific technical documents including GXP change control, formal SOPs, system validation protocols, etc. **Preferred Experience and Skills** While not required, experience in one or more of the following areas is beneficial. + Demonstrated commitment to diversity and inclusion. + Experience leading a team for a common goal + Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation management. + Experience supporting internal and external quality audits. + Experience in instrument computer system validation 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 . You can apply for this role through (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:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Required Skills:** Applied Engineering, Applied Engineering, Change Control Processes, Change Management, Coaching and Development, Computer System Validation (CSV), Corrective and Preventive Action (CAPA), Customer-Focused, Detail-Oriented, GMP Compliance, IS Audit, Lab Equipment Maintenance, Laboratory Maintenance, Lean Manufacturing, Learning New Concepts, Manufacturing, Production Management, Quality Auditing, Quality Control Documentation, Quality Control Management, Quality Improvement Programs, Quality Inspections, Quality Management Standards, Regulatory Compliance, Root Cause Analysis (RCA) {+ 4 more} **Preferred Skills:** **Job Posting End Date:** 09/20/2025 ***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:** R365924

Created: 2025-09-23