CQV Engineer: GMP-Driven Qualification & Validation

Eurofins

Lancaster (Lancaster County)

On-site

USD 90,000 - 130,000

Full time

45 hours ago
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Benefits offered by this job

Medical Insurance
Dental Insurance
Vision Insurance
401(k) with company match
Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services is seeking a hands-on CQV Engineer to lead commissioning, qualification and validation activities for pharmaceutical and biotechnology clients. You will author IQ/OQ/PQ protocols, perform field verifications, and build complete qualification packages with a focus on good documentation practices.

You will collaborate with site engineering and quality teams, support risk assessment and change control, and progressively own qualification workstreams while mentoring

Qualifications

  • Two or more years of hands-on GMP‑regulated experience in commissioning, qualification or validation.

Responsibilities

  • Author and execute IQ, OQ and PQ protocols for utilities, equipment and facilities.
  • Perform field verification and walkdowns against P&IDs; log discrepancies.
  • Execute qualification sampling programs and maintain complete records (logs, chain of custody, protocols).
  • Write deviation and summary reports; support investigations.
  • Support risk assessments and FMEAs; follow-on sampling plans.
  • Assist change control and close out qualification packages.
  • Collaborate with client engineering and quality teams on site.
  • As you grow, take ownership of systems end to end and mentor others.

Skills

GMP experience
IQ/OQ/PQ knowledge
Technical writing
Reading P&IDs

Education

Engineering degree
Biology/Life science degree

Job description

Eurofins USA BioPharma Services is seeking a hands-on CQV Engineer to lead commissioning, qualification and validation activities for pharmaceutical and biotechnology clients. You will author IQ/OQ/PQ protocols, perform field verifications, and build complete qualification packages with a focus on good documentation practices.

You will collaborate with site engineering and quality teams, support risk assessment and change control, and progressively own qualification workstreams while mentoring

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