CQV Engineer-Lab Expansion

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