We are seeking a CQV Engineer with a strong background in validation within a regulated pharmaceutical, biotechnology, or life sciences manufacturing environment. This position will primarily focus on the review of validation and qualification documentation to ensure accuracy, completeness, technical quality, and compliance with applicable regulatory and company requirements. The ideal candidate will have at least 3 years of validation experience, a solid understanding of the validation lifecycle, and hands-on experience with process equipment such as tanks, reactors, vessels, and related manufacturing systems.

CQV Engineer Responsibilities:

• Review commissioning, qualification, and validation documentation for accuracy, completeness, consistency, and compliance.

• Review protocols, test scripts, reports, deviations, and supporting validation documentation.

• Verify that qualification activities and documentation meet approved procedures, specifications, acceptance criteria, and applicable GMP requirements.

• Apply a strong understanding of the validation lifecycle, including commissioning, IQ, OQ, PQ, and validation closeout.

• Review documentation associated with process and manufacturing equipment, including tanks, reactors, vessels, and similar systems.

• Identify documentation gaps, discrepancies, and compliance concerns and work with Engineering, Validation, Quality, and Operations teams to resolve them.

• Ensure validation documentation follows Good Documentation Practices (GDP) and is inspection/audit ready.

• Support validation and qualification activities as needed.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred.

• 3+ years of validation/CQV experience within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.

• Experience with process equipment such as tanks, reactors, vessels, or similar manufacturing systems strongly preferred.

• Strong understanding of commissioning, qualification, and validation principles and lifecycle documentation.

• Knowledge of GMP and Good Documentation Practices.

• Demonstrated experience reviewing technical validation documentation.

• Excellent attention to detail and ability to identify documentation and compliance issues.

• Strong written and verbal communication skills.

• Ability to work effectively with Engineering, Quality, Validation, Manufacturing, and other cross-functional teams.