CQV Engineer

Katalyst Healthcares and Life Sciences

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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Vacancy posted 5 days ago

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