Validation Engineer
Overview Our client is seeking a Senior Validation Engineer to provide onsite support for Commissioning, Qualification, and Validation (CQV) and Equipment Validation activities. This role is based in Wisconsin and requires hands-on experience within a CDMO medical device manufacturing environment .
The ideal candidate will have a strong background working in manufacturing and contract manufacturing settings , with the ability to independently execute validation activities for production equipment.
Key Responsibilities Lead and execute CQV and Equipment Validation activities
Perform IQ, OQ, and PQ for manufacturing equipment
Develop, execute, and author validation protocols, reports, and SOPs
Conduct risk assessments , support process optimization, and continuous improvement initiatives
Perform API functional testing as part of equipment and process validation
Collaborate closely with manufacturing, quality, and engineering teams
Equipment Experience Bio Fillers
Cappers
Stoppers
Required Skills & Experience 8–10 years of experience in Validation Engineering
Strong hands-on experience with equipment validation (IQ/OQ/PQ)
Proven ability to write and execute validation documentation
Experience with risk assessment methodologies and optimization activities
Background supporting CDMO and medical device manufacturing environments
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