Engineer, QA Validation

We Are Hiring: Engineer, QA Validation!

Location: Novato, CA

Work Style: Hybrid

Duration: 6 months

Pay Rate: $45 to $51.30/hour

About The Role

We are seeking a QA Validation Engineer to support qualification and lifecycle management of equipment, facilities, and utilities within a GMP-regulated biologics environment. This role will play a key part in ensuring data integrity compliance and supporting quality oversight of new and existing systems, with a cross-functional reach spanning manufacturing, engineering, automation, and QC operations.

Key Responsibilities

• Review and approve qualification and validation documentation, including URS, functional specs, FAT/SAT, IQ/OQ/PQ protocols, and final reports.
• Perform Data Integrity Risk Assessments, define data life cycles, and implement mitigation strategies and controls.
• Ensure data integrity compliance with FDA, EMA, and other regulatory requirements.
  
  

Required Qualifications

• 5+ years of experience in a GMP-regulated environment (biotech/pharma preferred).
• Strong knowledge of validation lifecycle documentation (URS, IQ/OQ/PQ, commissioning, automation testing).
• Demonstrated experience in data integrity implementation and software validation in GMP environments.
• Familiarity with FDA, EMA, and global regulatory validation expectations.
  
  

Education

• BS degree in Engineering, Biological Sciences, Physical Sciences, or a related technical discipline.
• Project management training or certification preferred.
  
  

This is an exciting opportunity to contribute to critical quality operations in a fast-paced and impactful biotech environment. If you have a passion for ensuring compliance and driving improvements in validation practices, we want to hear from you!