About the role
Summary:
Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment.
Roles & Responsibilities:
- Perform CQV activities for standalone equipment.
- Author and execute IQ/OQ/PQ protocols, validation plans, and reports.
- Support FAT, SAT, commissioning, qualification, and validation activities.
- Perform risk assessments and support deviations, CAPA, and change control.
- Review vendor documentation, equipment manuals, and engineering drawings.
- Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11.
Education & Experience:
- 5+ years of CQV validation experience in Pharma/Biotech.
- Strong experience with standalone equipment qualification.
- Hands-on experience with IQ/OQ/PQ protocol authoring and execution.
- Knowledge of FDA, cGMP, GAMP 5, ISPE, and 21 CFR Part 11.
- Preferred Equipment
- Autoclaves, Washers, Bioreactors, Mixers, Tanks & Vessels, CIP/SIP Systems, Process Skids, Filling Equipment, Packaging Equipment, Incubators, and Freezers.
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