Senior Validation Engineer

We are seeking a Senior Validation & Facilities Engineer to join a fast‑paced GMP biotech environment in South San Francisco. This is a hands‑on, execution‑focused role for a senior‑level engineer who can independently own facility and equipment qualification activities.

The ideal candidate is technically strong, comfortable making risk‑based decisions, and confident challenging vendor documentation when needed.

This role offers the opportunity to own scope end‑to‑end, influence validation strategy, and move beyond rigid, template‑driven execution.

• Lead and execute facility and environmental qualification activities, including:
• Smoke studies / airflow visualization
• Pressurization and differential pressure studies
• Temperature mapping
• Environmental Monitoring Performance Qualification (EMPQ) support for GMP rooms
• Perform P&, redlines, and field verification

• Review and assess vendor commissioning, IQ, and OQ documentation for adequacy
• Determine when supplemental or wrapper protocols are required
• Define and justify representative qualification strategies
• Author and execute validation protocols and reports
• Support qualification of multiple process and laboratory equipment units

• Work closely with QA, Facilities, Engineering, Manufacturing, QC, and vendors
• Provide clear weekly progress updates and proactively identify risks

• 5+ of hands‑ validation and facilities engineering experience in a GMP biotech or pharmaceutical environment
• Proven experience leading validation execution, not just reviewing documents
• Strong technical 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

Mid‑Senior level

Contract

Pharmaceutical Manufacturing and Biotechnology Research