Specialist, Analytical Instrument Validation (On-site)
Merck
August 14, 2026
On-site
Rahway, NJ
Operations
Analytical Instrument Validation Specialist (Validation Specialist) — GMP environment (Rahway, NJ; multiple sites including PA, NJ, and Schachen, CH)
Key Responsibilities:
- Partner with scientific teams across DSCS to drive compliance and operational excellence
- Validate novel and time-sensitive computerized analytical instrumentation in GMP environments to 21 CFR Part 11 compliance
- Support standardization activities for System Development Life Cycle (SDLC) globally
- Support internal quality and external regulatory audits; maintain laboratory inspection readiness within SDLC scope
- Contribute to SOP drafting
- Originate and own Investigations and Change Management records
- Contribute to digital innovation activities to improve consistency, compliance, and efficiency
Education/Minimum Requirements:
- Bachelor’s degree (or higher) in analytical chemistry (or related field) with 3+ years post-degree relevant industry experience
Required Skills/Experience:
- Ability to work independently and cross-functionally in a fast-paced environment
- Proven technical and innovative problem solving
- Desire and ability to learn new concepts beyond core expertise
- Excellent verbal and written communication; strong interpersonal skills
- Industry experience with computerized equipment/instrument validation
- Experience working within a GMP environment
- Understanding of GMP policies and procedures
Preferred Skills/Experience (beneficial):
- IT/computerized systems/software/applications (e.g., Secure Desktop)
- Developing tools (e.g., Power Apps) or utilizing AI; leading teams
- Auditing and compliance experience (incl. change and deviation management)
- Internal/external quality audit support; instrument computer system validation
- Instrument commissioning/qualification/validation (CQV)
Required Skills (examples):
- Analytical chemistry, analytical instrumentation/equipment, data analysis, CSV, GMP compliance, SDLC, SOP writing, regulatory audits/compliance, change management.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting). Requisition ID: R395322.
Key Responsibilities:
- Partner with scientific teams across DSCS to drive compliance and operational excellence
- Validate novel and time-sensitive computerized analytical instrumentation in GMP environments to 21 CFR Part 11 compliance
- Support standardization activities for System Development Life Cycle (SDLC) globally
- Support internal quality and external regulatory audits; maintain laboratory inspection readiness within SDLC scope
- Contribute to SOP drafting
- Originate and own Investigations and Change Management records
- Contribute to digital innovation activities to improve consistency, compliance, and efficiency
Education/Minimum Requirements:
- Bachelor’s degree (or higher) in analytical chemistry (or related field) with 3+ years post-degree relevant industry experience
Required Skills/Experience:
- Ability to work independently and cross-functionally in a fast-paced environment
- Proven technical and innovative problem solving
- Desire and ability to learn new concepts beyond core expertise
- Excellent verbal and written communication; strong interpersonal skills
- Industry experience with computerized equipment/instrument validation
- Experience working within a GMP environment
- Understanding of GMP policies and procedures
Preferred Skills/Experience (beneficial):
- IT/computerized systems/software/applications (e.g., Secure Desktop)
- Developing tools (e.g., Power Apps) or utilizing AI; leading teams
- Auditing and compliance experience (incl. change and deviation management)
- Internal/external quality audit support; instrument computer system validation
- Instrument commissioning/qualification/validation (CQV)
Required Skills (examples):
- Analytical chemistry, analytical instrumentation/equipment, data analysis, CSV, GMP compliance, SDLC, SOP writing, regulatory audits/compliance, change management.
Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting). Requisition ID: R395322.