CQV Engineer

Katalyst CRO; Portland (ME); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO seeks a CQV Validation Engineer with 5+ years of pharma/biotech experience to lead commissioning, qualification and validation of standalone manufacturing equipment in a GMP setting.

You will author IQ/OQ/PQ protocols, review vendor docs, and support FAT/SAT and change control while ensuring FDA/cGMP/GAMP5/21 CFR Part 11 compliance.

Qualifications

• 5+ years of CQV validation experience in Pharma/Biotech.
• Hands-on standalone equipment qualification.
• Experience authoring IQ/OQ/PQ protocols and executing them.
• Knowledge of FDA, cGMP, GAMP 5, ISPE, and 21 CFR Part 11.

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

Regulatory compliance

Risk assessment

CAPA

Vendor docs review

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.