POSITION SUMMARY:
The Commissioning, Qualification, and Validation (CQV) Engineer (Passivation) is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility.
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Commission, qualify, and validate facilities, utilities, and equipment in accordance with project and regulatory requirements.
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Support the development, review, and execution of CQV documentation, including protocols, reports, and validation deliverables.
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Assists to review and qualify equipment for commissioning, qualification, and validation activities.
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Assist with equipment qualification activities and ensure systems meet design and operational requirements.
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Participate in risk assessments, design reviews, FAT, SAT, IQ, OQ, PQ, and PV activities.
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Collaborate with clients, contractors, vendors, and cross-functional teams to successfully deliver project objectives.
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Bachelor's Degree in Engineering, Life Sciences, or a related discipline.
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2+ years of experience in commissioning, qualification, and validation within pharmaceutical, biotech, or regulated environments.
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Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation.
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Experience developing SOPs, validation reports, and quality documentation.
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Good understanding of cGMP requirements and 21 CFR compliance.
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Previous experience with clean utility systems, particularly Purified Water (PW) and Water for Injection (WFI) systems.
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Experience commissioning, pressure testing, flushing, passivating, and qualifying pharmaceutical water systems.
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Knowledge of water system validation, sanitization, and lifecycle management activities.
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Strong communication, problem-solving, and stakeholder management skills.
