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.
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.
