CQV Engineer
Katalyst CRO · Concord, NC · 3 wk ago
On-siteEngineeringContract
About the role
A CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences to perform Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment.
Responsibilities
- Perform CQV activities for standalone equipment.
- Author and execute IQ/OQ/PQ protocols, validation plans, and reports.
- Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, and validation activities.
- Perform risk assessments and support deviations, Corrective and Preventive Actions (CAPA), and change control.
- Review vendor documentation, equipment manuals, and engineering drawings.
- Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11.
Requirements
- 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 Experience
- Autoclaves
- Washers
- Bioreactors
- Mixers
- Tanks & Vessels
- CIP/SIP Systems
- Process Skids
- Filling Equipment
- Packaging Equipment
- Incubators
- Freezers