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Job Description
Senior CQV Engineer at Meet Life Sciences Senior CQV Engineer at Meet Life Sciences in Boston, Massachusetts Posted in 5 days ago.
Type:
full-time
Job Description:
Job Summary The Senior CQV Engineer leads commissioning, qualification, and validation (CQV) activities for GMP manufacturing equipment, facilities, utilities, automation systems, and infrastructure . This role ensures systems are designed, installed, tested, and maintained in compliance with cGMP and regulatory requirements while supporting capital projects, facility expansions, and operational readiness initiatives. Responsibilities Lead CQV activities for GMP equipment, utilities, facilities, automation systems, and infrastructure. Develop and execute validation documentation, including plans, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and summary reports. Author, review, and approve SOPs, change controls, deviations, CAPAs, and validation lifecycle documents. Coordinate commissioning, startup, and qualification activities to support project timelines and operational readiness. Ensure compliance with c
GMP, FDA, EU
regulations, and data integrity requirements. Collaborate with cross-functional teams (Engineering, Manufacturing, Quality, Automation, Process Development) and external vendors. Support FATs, SATs, design reviews, construction walkdowns, and turnover documentation. Participate in audits and regulatory inspections as needed. Provide technical leadership, mentoring, and oversight to junior engineers and contractors. Support continuous improvement initiatives, risk reduction, and CQV process optimization. Qualifications Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field required. 6+ years of CQV experience in a GMP-regulated pharmaceutical, biotech, medical device, or life sciences environment. Strong knowledge of c
GMP, FDA, EU
regulations, and validation lifecycle principles. Experience leading CQV for GMP manufacturing equipment, utilities, facilities, and laboratory systems. Proficiency in writing and executing validation deliverables (IQ/OQ/PQ, risk assessments, traceability matrices, etc.). Experience supporting capital projects, equipment installations, and facility expansions. Knowledge of CSV, automation systems, and data integrity requirements preferred. Experience mentoring junior staff and collaborating across cross-functional teams.
