Validation Engineer
Technology
Ameri-partnersNorth Carolina, United States2 weeks ago
Service contractOn-site
Job description
Validation Engineer
Location: Raleigh, NC | OnsiteAmeri Partners is seeking a Validation Engineer to support equipment, utilities, facilities, processes, and systems in a regulated life sciences environment.
Responsibilities
- Develop, review, and execute FAT, SAT, IOQ, and PQ protocols and reports.
- Perform P&ID walkdowns, drawing reviews, ETOP verification, and thermal mapping.
- Support risk assessments, discrepancy resolution, requalification, and periodic reviews.
- Collaborate with Quality, Engineering, and Manufacturing to maintain cGMP compliance.
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 3–4 years of validation or engineering experience in pharma, biotech, or medical devices.
- Working knowledge of FDA cGMP, FMEA, and risk assessment.
- Strong technical writing and communication skills.
Keywords
environment-health-and-safety-hsseecology-environmentinstructional-design-idpiping-and-instrumentation-diagram-p-idassessment-assessment-toolsrisk-assessmentrisk-analysiscompliancebiotechnologymedical-devicesfood-and-drug-administration-fda-or-usfdafailure-mode-and-effects-analysis-fmea
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