CQV Engineer: GMP Qualification & Validation Lead

Eurofins; 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, vision

Job summary

Eurofins is seeking a hands-on CQV Engineer to support commissioning, qualification and validation for pharmaceutical and biotech facilities. You will author and execute IQ, OQ and PQ protocols, perform field verifications, and drive deviations and investigations in a GMP-regulated environment.

The role requires 2+ years GMP experience, ability to read P&IDs, strong technical writing, and willingness to work on site in Raleigh, NC with standard hours and occasional overtime; benefits include

Qualifications

• Two or more years of hands-on GMP experience in commissioning, qualification or validation.
• Understanding of IQ, OQ and PQ and why qualification documents matter.
• Ability to read and interpret technical drawings and P&IDs.
• Strong technical writing for regulator-ready documents.
• Familiarity with cGMP under 21 CFR Parts 210 and 211.

Responsibilities

• Author and execute IQ/OQ/PQ protocols for utilities, equipment and facilities.
• Perform field verifications and log discrepancies for resolution.
• Maintain complete qualification records including sample logs and cOw.
• Support risk assessments, FMEAs and sampling plans.
• Collaborate with client engineering and QA teams on site.

Skills

GMP experience

IQ/OQ/PQ understanding

P&ID reading

Technical writing

Driver's license

Education

Engineering, microbiology or life science degree

Tools

LIMS

GAMP 5

Job description

Eurofins is seeking a hands-on CQV Engineer to support commissioning, qualification and validation for pharmaceutical and biotech facilities. You will author and execute IQ, OQ and PQ protocols, perform field verifications, and drive deviations and investigations in a GMP-regulated environment.

The role requires 2+ years GMP experience, ability to read P&IDs, strong technical writing, and willingness to work on site in Raleigh, NC with standard hours and occasional overtime; benefits include