CQV Engineer-Lab Expansion
Listed on 2026-09-28
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Engineering
Quality Engineering, Validation Engineer, Pharma Engineer, Regulatory Compliance Specialist
Hiring: CQV Engineer Lab Expansion
Job Title: CQV Engineer Lab Expansion
Location: North Carolina Onsite
Duration: 12 Months
Employment Type: Contract W2
Pay Rate: $40/hr(DOE) on W2
We are seeking an experienced CQV Engineer to support laboratory expansion and equipment qualification activities within a regulated pharmaceutical/biotech environment.
Job Requirements:
Strong hands-on experience with laboratory equipment qualification
Experience executing FAT, SAT, IQ, OQ, and PQ
Knowledge of Computer System Validation (CSV)
Experience developing/reviewing URS, FS, and DS
Hands-on experience with Kneat
Strong understanding of 21 CFR Part 11, GxP, data integrity, and audit readiness
Experience performing risk assessments and reviewing vendor documentation
Ability to develop and execute qualification protocols and associated documentation
Understanding of FDA/EMA regulatory expectations
Strong documentation and cross-functional communication skills
Ability to support onsite activities and occasional weekend execution
Candidates must be able to provide 2 managerial references
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