Analytical Laboratory Metrology Specialist

Merck • Upper Gwynedd Township, PA

6d • Hybrid

About The Position

The Analytical Chemistry in Commercialization and Supply (ACDS) Operations and Compliance group has an exciting opportunity for Metrology Specialist positions at our Rahway, NJ and West Point, PA sites.
We are seeking highly talented and motivated individuals to serve in a metrology specialist role that is responsible for the oversight of regulated and non-regulated laboratory equipment in a fast-paced, multidisciplinary lab environment. The candidate will be involved in overseeing the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation(SDLC), and regulated systems retirement.

Requirements

• Experience working within a regulated (GMP) laboratory and adherence to data integrity and compliance principals
• Familiarity with analytical laboratory equipment including HPLCs, GCs, UVs, dissolution systems, IR, Karl Fischer, and dissolution with ability to troubleshoot them
• Highly organized/strong attention to detail and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks
• Technical and innovative problem-solving skills
• Capable of working both independently and within a cross-functional team to deliver complex objectives under aggressive timelines in a rapidly changing environment.
• Strong verbal and written communication skills with an eagerness to learn, adapt and improve subject matter expertise
• Strong interpersonal skills for interacting with a variety of on-site and off-site collaborators and partner groups
• B.S. Degree in Chemistry, Engineering or closely related scientific field

Nice To Haves

• Experience with maintenance of analytical instrumentation with ability to troubleshoot them
• Experience with computerized standalone systems GMP validation requirements (SDLC)
• Familiarity with authoring relevant instrument standard operating procedures (SOPs)
• Experience in internal/external quality inspections and audits
• Experience with change management and deviation management

Responsibilities

• Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation
• Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships
• Gain a working knowledge of laboratory equipment to facilitate troubleshooting and/or perform maintenance or calibration activities
• Participate in computer system validation activities associated with new or upgraded equipment or software packages
• Support the purchase, installation and equipment qualification of new laboratory equipment
• Collaborate with metrology and partner groups to drive quality, data integrity and operational excellence as well as process improvements, training and site support
• Originate and progress deviation and Change Management (CM) records to document impact of instrument changes and issues
• Perform and document investigations and assist in developing/implementing CAPA plans
• Support internal and external audits, while maintaining labs in a state of permanent inspection readiness
• Work both independently and collaboratively in a fast-paced, integrated, multidisciplinary team environment and partner network
• Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures, with a strong focus on data integrity

Benefits

• 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

What This Job Offers

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