Barrington James

Lead and execute validation activities including facility and equipment qualification in a GMP biotech setting. | 10+ years of hands-on validation and facilities engineering experience in GMP biotech or pharmaceutical environments, with proven leadership in validation execution. | 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