CQV Engineer: GMP‑Driven Commissioning & Validation

Eurofins BioPharma Product Testing North America; Raleigh (NC); In loco; USD 85.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Medical, dental and vision coverage

Descrizione del lavoro

Eurofins USA BioPharma Services in Raleigh, NC seeks a hands‑on CQV engineer to lead commissioning, qualification and validation activities for pharmaceutical and biotech clients. You will author and execute IQ/OQ/PQ protocols, perform field verifications, and manage documentation throughout qualification campaigns.

Ideal candidates have GMP experience, are comfortable working on active sites, and can develop end‑to‑end qualification workstreams while mentoring junior engineers.

Competenze

• Two or more years of hands-on GMP‑regulated experience in commissioning, qualification or validation.
• Understanding of IQ, OQ and PQ and why qualification docs matter.
• Ability to read technical drawings, especially P&IDs.
• Clear technical writing for regulator-ready documents.
• Familiarity with cGMP under 21 CFR Parts 210 and 211.
• Engineering or life science degree preferred; equivalent hands-on experience considered.
• Careful, accurate, and methodical with good document trail.
• Valid driver's license; able to work on active construction/manufacturing sites and occasionally long hours.

Mansioni

• Author and execute commissioning and qualification protocols — IQ, OQ and PQ.
• Perform field verification and walkdowns against P&IDs.
• Execute qualification sampling programs and maintain records.
• Write deviation reports and summary reports; support investigations.
• Support risk assessments and FMEAs and the sampling plans that follow.
• 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.

Conoscenze

GMP experience

IQ/OQ/PQ knowledge

P&ID reading

Technical writing

cGMP knowledge

Attention to detail

Driver's license

Formazione

Engineering or life science degree

Descrizione del lavoro

Eurofins USA BioPharma Services in Raleigh, NC seeks a hands‑on CQV engineer to lead commissioning, qualification and validation activities for pharmaceutical and biotech clients. You will author and execute IQ/OQ/PQ protocols, perform field verifications, and manage documentation throughout qualification campaigns.

Ideal candidates have GMP experience, are comfortable working on active sites, and can develop end‑to‑end qualification workstreams while mentoring junior engineers.