Senior CQV Validation Engineer - Pharma GMP

Katalyst-Healthcares-; Atlanta (GA); On-site; USD 110,000 - 145,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a CQV Validation Engineer with 5+ years in pharma/biotech to perform CQV for standalone manufacturing equipment in GMP-regulated environments.

Role requires authoring IQ/OQ/PQ protocols, executing validation plans, and supporting FAT/SAT, commissioning, and risk assessments. Knowledge of FDA, cGMP, GAMP 5 and 21 CFR Part 11 is essential; experience with autoclaves, bioreactors, CIP/SIP systems is preferred.

Qualifications

• 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.

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.

Skills

CQV Validation

Standalone Equipment

IQ/OQ/PQ Protocols

FDA & cGMP Knowledge

GAMP 5 & 21 CFR Part 11

Education

5+ years CQV in Pharma/Biotech

Tools

Autoclaves

Washers

Bioreactors

Mixers

Tanks & Vessels

CIP/SIP Systems

Process Skids

Filling Equipment

Packaging Equipment

Incubators

Freezers

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.

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.