CQV Engineer
Katalyst Healthcares & Life SciencesPortland, ME
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Overview
Remote
On-site
Job Description
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.
- 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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FAQs About CQV Engineer Jobs at Katalyst Healthcares & Life Sciences
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This job at Katalyst Healthcares & Life Sciences is located in Portland, ME, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
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