Spclst, Research

Merck • North Wales, PA

1d • Hybrid

About The Position

The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our Company's Research Laboratories Division is seeking applicants for a Metrology and Validation Specialist position available at the West Point, Pennsylvania research facility. The Metrology and Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The role oversees and supports the onboarding, qualification, validation, and routine maintenance of analytical equipment and instrumentation within a GMP environment.

Requirements

• A strong team player with the ability to work both independently and cross-functionally to deliver on complex objectives.
• Proven track record of strong technical and innovative problem solving.
• 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.
• Experience working within a GMP environment.
• Understanding of GMP policies and procedures.

Nice To Haves

• Related industry experience with metrology and equipment maintenance and calibration.
• Demonstrated commitment to 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 commissioning, qualification, and validation (CQV).
• Experience in instrument computer system validation.
• Experience with IT, computerized systems, software and applications, including Secure Desktop.
• Experience with developing tools (e.g., Power Apps) or utilizing AI.

Responsibilities

• Partner with scientific teams across DSCS to drive compliance and operational excellence
• Onboard, qualify, and maintain laboratory equipment and instrumentation in both GMP and non-GMP environment
• Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software packages in compliance with 21CFR11 compliance requirements.
• Prepare, review, and approve documentation such as master inventory lists, qualification documentation, calibration documentation, computer system inventories
• Support internal and external quality audits and maintain laboratory state of permanent inspection readiness
• Originate and own Investigations and Change Management records
• Collaborate with cross-functional teams to deliver department level priorities and initiatives.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level