We are looking for hands-on CQV Engineers to support a high-impact biologics project within a GMP-regulated environment. This is a fast-paced opportunity focused purely on execution of validation protocols ideal for professionals who thrive on the manufacturing floor.
Roles & Responsibilities:
Execute IQ/OQ protocols for process equipment
Perform equipment walkdowns and verify against design
Support SIP/CIP cycles, wet testing, and temperature mapping
Work with downstream equipment (chromatography, filtration, tank farms, etc.)
Document and execute validation activities in ValGenesis
Collaborate with QA/QC and Manufacturing teams
Education & Experience :
Strong experience in CQV / Validation (IQ/OQ)
Background in biologics / biopharma / cell culture
Hands-on experience with process equipment validation
Familiarity with GMP & GDP practices
Experience with downstream equipment
Numbers & Facts
Location
Devens, MA
Skills
CIP (Clean-in-Place)unmatched
Cell Culturesunmatched
Chromatographyunmatched
Design Verificationunmatched
Equipment Validationunmatched
GMP (Good Manufacturing Practices)unmatched
Manufacturingunmatched
Process Validationunmatched
Quality Assuranceunmatched
Quality Controlunmatched
SIP (Sterilization-in-Place)unmatched
Temperature Mappingunmatched
Validation Documentationunmatched
Validation Planunmatched
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