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CQV Consultant (Utilities & GMP Equipment)

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SmartIMS Inc.

Sacramento, CA (In Person)

Full-Time

Posted 2 days ago (Updated 7 hours ago) • Actively hiring

Expires 7/4/2026

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Job Description

•Onsite Role •Position Summary The selected candidate will be responsible for commissioning, qualification, and validation activities related to GMP utilities, manufacturing equipment, process systems, and supporting infrastructure within a regulated biotech environment. The role requires strong expertise in qualification lifecycle management, GMP compliance, equipment validation, and cross-functional collaboration with Engineering, Manufacturing, Quality Assurance, and Validation teams. Key Responsibilities Commissioning, Qualification & Validation (CQV) GMP Compliance & Documentation Cross-Functional Collaboration Computer System Validation (CSV) Required Qualifications Bachelor s degree in engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related discipline. Minimum 5+ years of experience in CQV within pharmaceutical, biotechnology, or regulated manufacturing environments. Hands-on experience executing
IQ/OQ/PQ
protocols. Experience with GMP manufacturing equipment and utility qualification. Technical Skills Equipment Qualification Bioreactors Fermenters CIP/SIP Systems Chromatography Systems Process Vessels Filling Equipment Packaging Equipment Utility Systems Purified Water Systems Water for Injection (WFI) Clean Steam Systems HVAC Systems Compressed Air Systems Nitrogen Systems Environmental Monitoring Systems Validation & Compliance Qualification Lifecycle Management Risk Assessments Change Control Deviation Management CAPA Validation Documentation Regulatory Knowledge c
GMP 21 CFR
Part 11 GAMP 5 ICH
Q9 ICH Q10
Preferred Qualifications Biotechnology manufacturing experience. Experience with automation systems and SCADA interfaces. Exposure to DeltaV, Rockwell, Siemens, or similar control systems. Prior experience supporting FDA, EMA, MHRA, or other regulatory inspections. Knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA).