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Katalyst Healthcares & Life Sciences

CQV Engineer

Pay: Not specified

Posted: 2 weeks ago

Location: Atlanta, GA (Onsite)

Last Updated: 2 weeks ago

Hours: Full-Time

Expires: 9/30/2026

Career Insights for Pharmaceutical Manufacturing Process Engineer

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What they do

A Pharmaceutical Manufacturing Process Engineer designs and maintains manufacturing equipment, facilities and processes for a pharmaceutical company. Maintains process controls for the specific sterile processing requirements of pharmaceutical manufacturing.

$111,597 / year median in Georgia

+23% projected growth

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Job Description

CQV Engineer Katalyst Healthcares & Life Sciences - 4.0 Atlanta, GA Job Details Contract 2 hours ago Qualifications Pharmaceutical regulatory compliance

FDA 21 CFR

Part 11 Production validation processes Biomedical regulatory compliance Commissioning phase involvement

Full 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, c

GMP, 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, c

GMP, 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.