Manufacturing Validation Engineer

Kelly Engineering is seeking a hands-on Manufacturing Validation Engineer to support critical validation work for a growing life sciences manufacturer in Petaluma, CA.

Location: Petaluma, CA
Schedule: 100% Onsite | Monday–Friday
Employment Type: Contract-to-Hire
Pay Rate: $60–$70/hr

This is a validation-heavy engineering role supporting equipment, process, and utility qualifications in a fast-paced GMP environment. The team is preparing for commercialization and needs someone who can independently own validation work from protocol writing through execution, deviation resolution, and final closeout.

This is not a general manufacturing engineering role. This position is best suited for someone who has personally authored and executed validations in regulated manufacturing and can work independently in a startup environment with minimal handholding.

What You’ll Do:

• Independently author, execute, and close validation protocols for equipment, utilities, and manufacturing processes
  

• Lead IQ, OQ, and PQ activities for laboratory and manufacturing equipment
  

• Write validation protocols, final reports, deviations, work instructions, and supporting technical documentation
  

• Own validation deviations from investigation through documentation and resolution
  

• Establish process controls and technical documentation for validated systems
  

• Lead equipment qualification and commissioning activities for new and existing systems
  

• Troubleshoot validation failures and resolve technical issues during execution
  

• Support validation of laboratory and manufacturing equipment including incubators, refrigeration systems, and controlled process equipment
  

• Support qualification of facility and utility systems including water systems, piping, and related infrastructure
  

• Participate in risk assessments, FMEA, and validation impact assessments
  

• Support engineering studies and DOE activities to define process tolerances and improve validation robustness
  

• Partner cross-functionally with Quality, Manufacturing, and R&D to ensure validated systems are compliant and production-ready

What You’ll Need:

• Bachelor’s degree in Engineering or related technical discipline preferred
  

• 5–7+ years of hands-on validation experience in regulated manufacturing environments
  

• Strong experience independently authoring and executing IQ, OQ, and PQ protocols
  

• Proven experience owning validation work from protocol development through execution and final report closeout
  

• Demonstrated experience writing deviations, technical investigations, and validation documentation independently
  

• Experience supporting equipment qualification, process validation, and utility/facility validation
  

• Strong understanding of GMP and FDA-regulated environments such as pharmaceutical, biotechnology, medical device, or combination product manufacturing
  

• Working knowledge of quality systems and regulatory frameworks including GMP, 21 CFR Part 820, 21 CFR Part 211, and related validation standards
  

• Ability to troubleshoot technical issues during validation and make sound engineering decisions in real time
  

• Strong technical writing skills and ability to produce clear, compliant documentation
  

• Comfortable working independently in a fast-moving startup environment with evolving priorities

Ideal Background:

• Validation Engineering
  

• Manufacturing Validation
  

• Process Validation
  

• Equipment Qualification
  

• GMP / FDA-regulated manufacturing
  

• Pharmaceutical, biotech, medical device, or combination product environments

Candidates with primarily lean manufacturing, continuous improvement, or general production engineering backgrounds without direct validation ownership are unlikely to be a fit.

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