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CQV Consultant

Job

SmartIMS Inc.

Sacramento, CA (In Person)

Full-Time

Posted 2 days ago (Updated 8 hours ago) • Actively hiring

Expires 7/4/2026

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Job Description

Onsite in Sacramento, California CQV Consultant . 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. Computer System Validation (CSV) Support CSV activities associated with equipment software, automation systems, and equipment-to-system interfaces. Review software configuration documentation and validation evidence. Assist in validation of GMP computerized systems associated with manufacturing operations. Required Qualifications Education Bachelor s degree in engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related discipline. Experience 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. Exposure to commissioning and startup activities Regulatory Knowledge c
GMP 21 CFR
Part 11 GAMP 5 ICH Q9 ICH Q10