CQV Engineer: GMP Validation & Commissioning

Eurofins USA BioPharma Services; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Medical, dental, and vision coverage

Job summary

Eurofins USA BioPharma Services in Raleigh, NC is seeking a hands-on CQV Engineer to lead commissioning, qualification and validation activities for pharmaceutical and biotechnology projects. You will author and execute IQ, OQ and PQ protocols, perform field verifications, and manage documentation trails.

You will work with client engineering and quality teams on site, mentor newer engineers as you grow, and eventually own qualification workstreams.

Qualifications

• Two or more years of hands-on experience in a GMP-regulated environment.
• Familiar with 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-read documents.
• Familiarity with cGMP under 21 CFR Parts 210 and 211, and good documentation practice.

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 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

IQ/OQ/PQ

Technical writing

P&IDs literacy

Reading technical drawings

Driver's license

Education

Engineering or life sciences degree

Job description

Eurofins USA BioPharma Services in Raleigh, NC is seeking a hands-on CQV Engineer to lead commissioning, qualification and validation activities for pharmaceutical and biotechnology projects. You will author and execute IQ, OQ and PQ protocols, perform field verifications, and manage documentation trails.

You will work with client engineering and quality teams on site, mentor newer engineers as you grow, and eventually own qualification workstreams.