CQV Engineer

JobDiva, Inc.; Portland (ME); On-site; USD 90,000 - 140,000; Full time

Job summary

JobDiva, Inc. in Portland, ME is seeking a CQV Validation Engineer with 5+ years of experience in pharma, biotech, or life sciences to lead commissioning, qualification and validation of standalone manufacturing equipment within a GMP-regulated environment.

You will author and execute IQ/OQ/PQ protocols, validate systems, review vendor documentation, and support risk assessments, CAPA, and change control to ensure FDA and 21 CFR Part 11 compliance.

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.

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.

Skills

IQ/OQ/PQ execution

Regulatory compliance

Documentation & reporting

Risk assessment

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.