Specialist, Metrology and Validation (On-site)

Metrology and Validation Specialist (Rahway, New Jersey)

Responsibilities
- Partner with DSCS scientific teams to drive compliance and operational excellence.
- Onboard, qualify, and maintain laboratory equipment and instrumentation in GMP and non-GMP environments.
- Participate in laboratory computer system validation for new/upgraded instrumentation or software (21 CFR Part 11).
- Prepare/review/approve documentation including master inventory lists, qualification and calibration documentation, and computer system inventories.
- Support internal and external quality audits and maintain inspection readiness.
- Author or contribute to SOPs.
- Originate and own Investigations and Change Management records.
- Collaborate with cross-functional teams to deliver department priorities.

Qualifications
- Bachelor’s degree (or higher) in analytical chemistry or related field with 3+ years relevant industry experience.

Required experience/skills
- Work independently and cross-functionally in a fast-paced, multidisciplinary team.
- Strong technical/innovative problem solving.
- Learn new concepts beyond core expertise.
- Excellent verbal/written communication and interpersonal skills.
- Metrology and equipment maintenance/calibration experience.
- Experience in and understanding of GMP policies/procedures.

Preferred experience/skills (beneficial)
- Auditing/compliance; change/deviation management.
- Instrument commissioning/qualification/validation (CQV) and instrument computer system validation.
- IT/computerized systems/software (incl. Secure Desktop); developing tools (e.g., Power Apps) or using AI.

Application instructions
- Apply via https://jobs.merck.com/us/en (deadline listed on the posting).