Requisition ID: RES002199
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Analytical Commercialization Technology - Pharmaceuticals group currently has an exciting opportunity for a Metrology Specialist at our Rahway, New Jersey site. We are seeking a highly talented and motivated individual to serve in a metrology specialist role that is responsible for the oversight of regulated and non-regulated laboratory equipment. The candidate will be involved in overseeing the lifecycle of the lab instrumention covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement.
Position 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 with 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 staff across multiple testing labs and sites for process improvement, cross-training and cross-site support
- Originate and progress Notice of Event (NOE) and Change Management (CM) records;
- Perform and document investigations and assist in developing/implementing CAPA plans;
- Represent the laboratory on all aspects of laboratory equipment during audits
- Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures
Education Minimum Requirement:
- B.S. Degree in Chemistry , Biochemistry, or closely related sciences with at least 3 years of industry experience or an M.S. with at least 1 year of related experience.
Required Experience and Skills**:
- Experience working within a regulated (GMP) laboratory
- Experience maintaining laboratory equipment including HPLCs, GCs, UVs, dissolution systems, or other specialized computerized systems
- Familiarity with standalone computer system validation requirements
- Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks
- Capable of working independently under moderate supervision
- Strong verbal and written communication skills
- Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators
Preferred Experience and Skills:
- Experience with maintainance of analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolution with ability to troubleshoot them.
- Experience with computerized standalone systems GMP validation requirements
- Familiarity with authoring relevant instrument standard operating procedures (SOPs)
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Visa sponsorship is not available for this position.