CQV Engineer: GMP Validation Leader in Bay Area

engineeringjobs.net, Inc.; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Validation & Engineering Group is seeking a CQV Engineer to support a pharmaceutical/biotechnology project in the Bay Area. The ideal candidate will have 24 years of experience in commissioning, qualification, validation, or project engineering within a regulated industry.

The role involves FAT execution, documentation, and collaboration with vendors and client teams to ensure GMP compliance and project quality. On-site work in the Bay Area is expected for the duration of the project.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline preferred.
• 24 years of experience in CQV validation, commissioning, project engineering or a related field.
• Experience with FAT execution and technical documentation.
• Knowledge of vessels, piping, equipment and engineering drawings.
• Pharmaceutical/biotech/medical device or other regulated industry experience preferred.
• Ability to work on site in the Bay Area, 40 hours per week for the duration of the project.

Responsibilities

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

Skills

CQV expertise

Regulated industry experience

Commissioning

Project engineering

Documentation

Education

Bachelor's degree in Engineering

Job description

Validation & Engineering Group is seeking a CQV Engineer to support a pharmaceutical/biotechnology project in the Bay Area. The ideal candidate will have 24 years of experience in commissioning, qualification, validation, or project engineering within a regulated industry.

The role involves FAT execution, documentation, and collaboration with vendors and client teams to ensure GMP compliance and project quality. On-site work in the Bay Area is expected for the duration of the project.