CQV Engineer

Creative Solutions Services, LLC; Concord (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

A CQV Validation Engineer role is available for candidates with 5+ years of CQV experience in pharma/biotech. You will perform CQV activities on standalone equipment and author IQ/OQ/PQ protocols, plans, and reports.

Join a team that supports FAT, SAT, commissioning, quality deviations, CAPA, and change control while ensuring compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11.

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.
• Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11.

Skills

CQV validation

Pharma/Biotech experience

IQ/OQ/PQ execution

FDA/cGMP knowledge

GAMP 5 / 21 CFR Part 11

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.