CQV Engineer
CQV Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Location: California (on site local candidates only)
Experience: 4 5 years in pharmaceutical/biotech manufacturing environments
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Lead and execute CQV activities for equipment utilities and facility systems in compliance with GMP/FDA/EMA regulations: commissioning IQ/OQ/PQ cleaning validation facility and software validation
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Develop and review lifecycle documentation such as Validation Master Plans URS FS Design Spec protocols risk assessments (FMEA HAZOP) SOPs and change control/MOC records
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Support FAT/SAT installation checks and daily job site walks with full PPE for construction oversight in active pharmaceutical facilities
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Collaborate cross-functionally with QA Operations Engineering and project stakeholders to resolve deviations CAPAs and ensure audit readiness
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Prepare summary reports and final validation packages documenting deviations corrective actions and performance metrics
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Provide guidance or mentorship to junior engineers; support training project close-out and continuous improvement initiatives
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Bachelors degree in Engineering (Chemical Mechanical Biomedical) or Life Sciences
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4 5 years of CQV experience in pharmaceutical manufacturing including utilities process equipment (e.g. vessels centrifuges WFI CIP skids HVAC cleanrooms)
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Demonstrated expertise in writing and executing IQ OQ PQ protocols commissioning plans FAT/SAT testing and risk-based validation strategies (e.g. ASTM E2500 or GAMP style)
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Solid knowledge of cGMP GxP FDA regulations and good documentation practices (GDP)
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Strong technical writing analytical problem solving and organizational skills; proficiency with Microsoft Office suite and document control systems
Employment Type
Full-time
