Validation Specialist IV - Vacaville, CA (Onsite, 5 days/week)

About the Role

As a Validation Specialist IV, you will play a critical part in defining validation and qualification strategies and coordinating testing activities across multiple operational areas. You'll partner cross‑functionally to ensure the facility meets all regulatory, quality, and operational requirements across the full validation life-cycle.
This is a fully onsite role requiring strong hands‑on experience and the ability to work closely with site teams daily.

Key Responsibilities

• Develop and define qualification and validation strategies for assigned projects.
• Coordinate testing activities in support of ongoing manufacturing operations.
• Execute and oversee validation efforts including:
  • Equipment/Utility/Facility Qualification
  • Cleaning Validation
  • Steaming/Sanitization/Sterility Validation across the validation lifecycle
• Ensure all validation activities adhere to regulatory and site compliance standards.
• Collaborate with cross‑functional teams (Engineering, Quality, Operations) to ensure successful execution of validation deliverables.

Required Experience

• Minimum 7 years of experience in validation within biotech, pharma, or related regulated industries.
• Extensive hands‑on experience in equipment validation - must be strong in execution and strategy.
• Ability to work onsite 5 days per week with cross‑functional teams.
• Demonstrated capability to manage validation activities across the full lifecycle.