What are the responsibilities and job description for the Senior Validation Engineer position at United Pharma Technologies Inc?
Role: Senior Validation & Facilities Engineer
Location: South San Francisco, CA
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.
Key Responsibilities
Facility & Environmental Qualification
- 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&ID walkdowns, redlines, and field verification
Validation Execution & Strategy
- 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
Cross-Functional Collaboration
- Work closely with QA, Facilities, Engineering, Manufacturing, QC, and vendors
- Provide clear weekly progress updates and proactively identify risks
Required Qualifications
- 5 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 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