CQV Engineer: GMP Validation & Commissioning

Eurofins BioPharma Product Testing North America; Edison (NJ); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services in Edison, NJ is seeking a hands-on commissioning, qualification and validation engineer to join our CQV team. You will author and execute IQ/OQ/PQ protocols, perform field verifications against P&IDs and build toward owning qualification workstreams.

This full-time role requires GMP experience, familiarity with 21 CFR Parts 210/211, and strong technical writing. You will collaborate with client engineering and quality teams on site, mentor newer engineers and

Qualifications

• Two or more years of hands-on experience in a GMP-regulated environment with commissioning, qualification or validation activity.
• Working understanding of IQ, OQ and PQ and why qualification documentation matters.
• Ability to read and work from technical drawings, particularly P&IDs.
• Clear technical writing for regulator-facing documents.
• Familiarity with 21 CFR Parts 210 and 211 and good documentation practice.
• Degree in engineering, microbiology or life sciences preferred; equivalents considered.
• Careful, accurate, and methodical with document trails.
• Valid driver's license and ability to work on active construction/manufacturing sites with occasional long hours.

Responsibilities

• Author and execute commissioning and qualification protocols — IQ, OQ and PQ — for utilities, equipment and facilities.
• Perform field verification and walkdowns against P&IDs and log discrepancies for resolution.
• Execute qualification sampling programs and maintain complete records (sample logs, chain of custody, protocols).
• Write deviation and summary reports and support investigations.
• Support risk assessments and FMEAs and the related sampling plans.
• Support change control and help close out qualification packages.
• Collaborate with client engineering and quality teams on site, representing Eurofins professionally.
• As you grow: take ownership of systems end to end, mentor newer engineers, and lead your own qualification workstreams.

Skills

GMP experience

Technical writing

Read drawings

Attention to detail

Driver's license

Education

Engineering or life sciences degree

Tools

P&IDs

GAMP 5 concepts

Job description

Eurofins USA BioPharma Services in Edison, NJ is seeking a hands-on commissioning, qualification and validation engineer to join our CQV team. You will author and execute IQ/OQ/PQ protocols, perform field verifications against P&IDs and build toward owning qualification workstreams.

This full-time role requires GMP experience, familiarity with 21 CFR Parts 210/211, and strong technical writing. You will collaborate with client engineering and quality teams on site, mentor newer engineers and