Job Details

We are supporting a biotech client in South San Francisco that is seeking a Senior Validation & Facilities Engineer to step into an execution-heavy GMP environment and take ownership of facility and equipment qualification activities.

This is not a junior validation role and not a project management position. The client needs a hands-on senior engineer who can independently assess risk, define appropriate validation strategy, challenge vendor documentation when necessary, and execute qualification work with minimal oversight.

This is a great opportunity to truly own scope rather than operate under rigid templates!

Responsibilities

• Lead and execute facility and environmental qualification activities, including:
• Smoke studies / airflow visualization
• Pressurization and differential pressure studies
• Temperature mapping
• EMPQ support for GMP rooms
• Review and assess vendor commissioning and IOQ documentation for adequacy
• Determine when supplemental or wrapper protocols are required
• Support qualification of process and laboratory equipment (multiple units)
• Apply and justify representative qualification strategies where appropriate
• Perform P&ID walkdowns, redlines, and field verification
• Author and execute validation protocols and reports
• Coordinate with QA, Facilities, Engineering, Manufacturing, QC, and vendors
• Provide clear weekly progress updates and flag risks early

Requirements:

• 10+ years of hands-on validation and facilities engineering experience in a GMP biotech or pharmaceutical environment
• Proven experience leading validation execution, not just reviewing documents
• Strong background in:
• Facility qualification and EMPQ
• HVAC systems
• Smoke studies / airflow visualization
• Temperature mapping
• Utilities and process equipment qualification
• Comfortable making risk-based decisions and defending technical judgment
• Able to work fully onsite in a fast-moving environment