Senior CQV Engineer – Pharma Validation & Commissioning

Validation & Engineering Group; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Validation & Engineering Group is seeking a CQV Engineer to support a pharmaceutical/biotech project in the Bay Area. The ideal candidate will bring extensive commissioning, qualification, validation or project engineering experience within regulated environments and hands-on FAT execution.

You will collaborate with CQV vendors and client teams, review engineering drawings, ensure GMP compliance, and contribute to documentation readiness.

Qualifications

• Bachelors degree in Engineering or a related technical discipline preferred.
• 24 years of experience in CQV validation commissioning or project engineering in a regulated industry.
• Experience with FAT execution and technical documentation.
• Knowledge of vessels piping equipment and engineering drawings.
• Pharmaceutical biotechnology medical device or other regulated industry experience preferred.
• Strong technical documentation communication and problem solving skills.
• Ability to work on site in the Bay Area 40 hours per week for the duration of the project.

Responsibilities

• Support FAT Factory Acceptance Testing activities including execution documentation and issue resolution.
• Provide project engineering support for vessels piping equipment and related systems.
• Review and interpret engineering drawings specifications and technical documentation.
• Support equipment and system readiness activities in accordance with project requirements.
• Collaborate with engineering CQV vendors and client teams to identify and resolve technical issues.
• Ensure activities and documentation comply with applicable GMP and project quality requirements.
• Participate in meetings walkdowns inspections and other project activities as required.

Skills

CQV

Validation

Commissioning

Project engineering

GMP compliance

Education

Bachelor's degree in Engineering

Tools

FAT execution

Engineering drawings

Job description

Validation & Engineering Group is seeking a CQV Engineer to support a pharmaceutical/biotech project in the Bay Area. The ideal candidate will bring extensive commissioning, qualification, validation or project engineering experience within regulated environments and hands-on FAT execution.

You will collaborate with CQV vendors and client teams, review engineering drawings, ensure GMP compliance, and contribute to documentation readiness.