Manufacturing Engineer

Manufacturing Validation Engineer

Petaluma, CA

Onsite | Contract-to-Hire | $60–$75 per hour

Kelly Engineering is seeking an experienced Manufacturing Validation Engineer to support equipment and process validations for a growing life sciences manufacturing organization in the North Bay. This role will play a key part in helping the manufacturing team complete critical validations as the company prepares for commercialization and production scale-up.

This position is ideal for engineers who have strong hands-on validation experience in regulated environments and can independently write and execute validation protocols, address deviations, and support the qualification of manufacturing and laboratory systems.

This is a contract-to-hire opportunity based on performance and business needs.

Schedule: Monday through Friday onsite. Some overtime or occasional weekend work may be required based on business needs in a fast-moving startup environment.

What You Will Do

• Execute equipment and process validations including IQ, OQ, and PQ

• Author validation protocols, reports, work instructions, and supporting documentation

• Support equipment commissioning, qualification, and troubleshooting activities

• Investigate and document validation deviations, ensuring clear and compliant technical documentation

• Establish process controls and documentation for validated equipment and systems

• Collaborate with Quality, Manufacturing, and R&D teams to support production readiness and scale-up activities

• Perform risk assessments including FMEA and validation impact assessments

• Support change control, deviation investigations, and CAPA activities within a regulated quality system

• Validate laboratory and manufacturing equipment such as incubators, refrigeration systems, and other controlled equipment

• Support validation activities for facility and utility systems including water systems, piping, and related infrastructure as needed

• Participate in engineering studies or DOE activities to support process understanding and operational tolerances

• Identify opportunities to improve manufacturing processes, quality systems, and operational efficiency

What You Need

• Bachelor’s degree in Engineering or a related technical field preferred

• 5–7+ years of experience in regulated manufacturing environments such as pharmaceutical, biotechnology, medical device, or combination product manufacturing

• Strong hands-on experience executing IQ, OQ, and PQ validation protocols

• Demonstrated experience writing validation documentation, technical reports, deviations, and work instructions

• Knowledge of FDA-regulated manufacturing environments and quality systems (such as 21 CFR Part 820, 211, or similar GMP frameworks)

• Experience supporting equipment qualification, facility systems, or process validation efforts

• Ability to troubleshoot equipment and manufacturing processes during validation activities

• Strong written documentation skills and attention to regulatory compliance

• Ability to work cross-functionally with Quality, Manufacturing, and Engineering teams

This role requires a proactive engineer who can work independently, communicate clearly, and adapt within a collaborative startup team environment where priorities evolve as the organization scales manufacturing operations.