Validation Engineer- Manufacturing

Kelly Engineering has an outstanding opportunity for a contract to hire Validation Engineer role with an organization that is committed to advancing solutions for some of the most challenging issues in healthcare in Petaluma, CA.

You will be working with innovative technologies to improve outcomes across a wide range of medical applications, from patient care settings to medical product development. With substantial growth ahead and an upcoming public offering, this is an exceptional opportunity to join a dynamic company offering significant equity potential.

Key Responsibilities:
Execute equipment, process, cleaning, and computerized system validations under approved validation plans
Author and execute IQ/OQ/PQ protocols, test scripts, and validation reports for a variety of equipment and systems
Support validation of manufacturing equipment, laboratory instruments, utilities, and supporting systems
Ensure validation activities comply with GMP, FDA, and applicable ISO standards
Assist with deviation investigations, root cause analysis, and CAPA implementation related to validation activities
Maintain complete, accurate, and inspection-ready validation documentation

Skills & Qualifications:
2+ years of experience in a GMP-regulated environment (pharmaceutical, biotechnology, medical device, or combination products)
Hands-on experience executing validation activities for equipment and processes
Ability to independently write and execute validation protocols with attention to detail and compliance
Working knowledge of ISO 13485 (preferred) and FDA quality system requirements
Comfortable working in a fast-paced, evolving, startup-like environment
Strong organizational, communication, and problem-solving skills


What happens next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in the Kelly Engineering network. That means our team of expert engineering recruiters will have access to your profile, making your opportunities limitless.
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