Sr. Validation and Facilities Engineer

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 :