GMP Analytical Instrument Validation Specialist

Merck; Rahway (NJ); On-site; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc., Rahway, NJ, USA, is seeking an Analytical Instrument Validation Specialist to join the ECVC department in the Rahway research facilities. This role supports validation of novel computerized instrumentation in GMP environments across multiple sites, driving quality, compliance, and SDLC standardization.

The successful candidate will collaborate across DSCS, contribute to SOPs, investigations, and change management, and participate in digital innovation initiatives to improve

Qualifications

• Bachelor’s degree in analytical chemistry or related field with ≥3 years industry experience.
• Ability to work independently and cross-functionally within GMP environments.
• Excellent verbal and written communication and problem-solving skills.

Responsibilities

• Partner with scientific teams across DSCS to drive compliance.
• Validate novel instrumentation in GMP environments to 21CFR11.
• Support SDLC standardization across the network.
• Assist audits and maintain inspection readiness.
• Draft and contribute to SOPs.
• Own Investigations and Change Management records.
• Contribute to digital innovations for efficiency and compliance.

Skills

Team collaboration

Instrument validation

GMP knowledge

Communication skills

Education

Bachelor'sdegree in analytical chemistry or related field

Tools

Power Apps

Computerized systems

Job description

Merck & Co., Inc., Rahway, NJ, USA, is seeking an Analytical Instrument Validation Specialist to join the ECVC department in the Rahway research facilities. This role supports validation of novel computerized instrumentation in GMP environments across multiple sites, driving quality, compliance, and SDLC standardization.

The successful candidate will collaborate across DSCS, contribute to SOPs, investigations, and change management, and participate in digital innovation initiatives to improve