CQV Engineer – GMP Validation & Commissioning

Eurofins USA BioPharma Services; Edison (NJ); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services in Edison, NJ, is hiring a CQV Engineer to lead commissioning, qualification and validation activities for pharmaceutical facilities. This full‑time role involves writing and executing IQ/OQ/PQ protocols, performing field walkdowns, and documenting results in support of FDA‑readiness.

You will work with client engineering and quality teams, grow toward owning systems end to end, mentor newer engineers, and contribute to risk assessments and change control while

Qualifications

• Two or more years of hands‑on experience in a GMP‑regulated environment, with direct involvement in commissioning, qualification or validation activity.
• A working understanding of IQ, OQ and PQ, and of why qualification documentation matters.
• Ability to read and work from technical drawings, particularly P&IDs.
• Clear technical writing. Much of this role is producing documents that a regulator may read.
• Familiarity with cGMP under 21 CFR Parts 210 and 211, and with good documentation practice.
• Degree in engineering, microbiology or a life science is preferred.

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, accurate records — sample logs, chain of custody and executed protocols.
• Write deviation reports and summary reports, and support investigations.
• Support risk assessments and FMEAs, and the sampling plans that follow from them.
• Support change control, and help close out qualification packages.
• Work 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

Reading P&IDs

Documentation discipline

Problem solving

Education

Engineering degree

Microbiology or life science degree

Tools

MODA

LIMS

Job description

Eurofins USA BioPharma Services in Edison, NJ, is hiring a CQV Engineer to lead commissioning, qualification and validation activities for pharmaceutical facilities. This full‑time role involves writing and executing IQ/OQ/PQ protocols, performing field walkdowns, and documenting results in support of FDA‑readiness.

You will work with client engineering and quality teams, grow toward owning systems end to end, mentor newer engineers, and contribute to risk assessments and change control while