Validation Engineer
Job in
Janesville, Rock County, Wisconsin, 53546, USA
Listed on 2026-02-12
Listing for:
United Pharma
Full Time
position Listed on 2026-02-12
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering, Medical Device Industry -
Manufacturing / Production
Validation Engineer, Quality Engineering, Medical Device Industry
Job Description & How to Apply Below
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.
- 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
- Bio Fillers
- Cappers
- Stoppers
- 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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