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CQV Engineer

Katalyst Healthcares and Lifesciences

Atlanta, Georgia • 11d ago

Full-time

CQV Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey • 11d ago

Full-time

Job Details

Skills

Life Sciences
Manufacturing
GMP
Risk Assessment
Corrective And Preventive Action
Change Control
Documentation
Regulatory Compliance
Pharmaceutics
IQ
OQ
PQ
Good Manufacturing Practice
GAMP
SIP

Summary

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.
uthor 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
utoclaves, Washers, Bioreactors, Mixers, Tanks & Vessels, CIP/SIP Systems, Process Skids, Filling Equipment, Packaging Equipment, Incubators, and Freezers.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: fb6eb6485e2acb3ed5250f2c241d18a4
Posted 30+ days ago

Fitment

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Job Details

Skills

Life Sciences
Manufacturing
GMP
Risk Assessment
Corrective And Preventive Action
Change Control
Documentation
Regulatory Compliance
Pharmaceutics
IQ
OQ
PQ
Good Manufacturing Practice
GAMP
SIP

Summary

Perform CQV activities for standalone equipment.
uthor 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
utoclaves, Washers, Bioreactors, Mixers, Tanks & Vessels, CIP/SIP Systems, Process Skids, Filling Equipment, Packaging Equipment, Incubators, and Freezers.

Dice Id: 91116760
Position Id: fb6eb6485e2acb3ed5250f2c241d18a4
Posted 30+ days ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

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USD 150,000.00 - 178,000.00 per year