Commissioning, Qualification, and Validation (CQV) Engineer
Eurofins Agroscience Services North Carolina
Eurofins seeks a CQV Engineer to author and execute commissioning, qualification, and validation protocols for pharmaceutical and biotechnology facilities. This hands-on role offers growth toward independent system ownership, working alongside senior engineers on IQ, OQ, and PQ programs for utilities, equipment, and infrastructure.
Responsibilities
- Author and execute IQ, OQ, and PQ protocols for utilities, equipment, and facilities
- Perform field verification and walkdowns against P&IDs; document discrepancies for resolution
- Execute qualification sampling programs and maintain complete records including sample logs and chain of custody
- Write deviation and summary reports; support investigations and change control activities
- Support risk assessments, FMEAs, and sampling plan development; close out qualification packages
Requirements
- Two or more years of hands-on GMP-regulated environment experience with direct commissioning, qualification, or validation involvement
- Working understanding of IQ, OQ, and PQ protocols and regulatory documentation requirements
- Ability to read and interpret technical drawings, particularly P&IDs
- Clear technical writing skills suitable for regulatory review
- Familiarity with cGMP under 21 CFR Parts 210 and 211 and documentation practices
- Engineering, microbiology, or life science degree preferred; equivalent hands-on experience considered
- Valid driver's license and ability to work on active manufacturing sites, including gowned environments
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