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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
