CQV Engineer: GMP Field Qualification and Systems Owner

Eurofins BioPharma Product Testing North America; Boston (KY); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services is seeking an hands-on CQV engineer to support commissioning, qualification and validation for pharma/biotech clients. You will author IQ/OQ/PQ protocols, perform field verifications, manage logs, and help drive quality documentation on site in a GMP environment.

As you grow, you will own qualification workstreams end-to-end, mentor new engineers, and coordinate with client teams to ensure compliant, efficient project execution.

Qualifications

• Two or more years in a GMP-regulated environment with commissioning, qualification or validation activity.
• Understanding of IQ, OQ and PQ and why qualification docs matter.
• Ability to read from technical drawings, especially P&IDs.
• Clear technical writing for regulator-read documents.
• Familiarity with cGMP under 21 CFR Parts 210 and 211.

Responsibilities

• Author and execute IQ/OQ/PQ for utilities, equipment and facilities.
• Perform field verifications and log discrepancies for resolution.
• Execute qualification sampling programs and maintain logs and COC.
• Write deviation and summary reports and support investigations.
• Support risk assessments, FMEAs and downstream sampling plans.
• Assist change control and close out qualification packages.
• Collaborate with client engineers and quality teams on site.
• Grow to own systems end-to-end and mentor others.

Skills

GMP experience

Technical writing

Read P&IDs

Education

Engineering or life science degree

Job description

Eurofins USA BioPharma Services is seeking an hands-on CQV engineer to support commissioning, qualification and validation for pharma/biotech clients. You will author IQ/OQ/PQ protocols, perform field verifications, manage logs, and help drive quality documentation on site in a GMP environment.

As you grow, you will own qualification workstreams end-to-end, mentor new engineers, and coordinate with client teams to ensure compliant, efficient project execution.