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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Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.