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Validation Engineer
Job in
Bethel, Fairfield County, Connecticut, 06801, USA
Listed on 2026-02-16
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-02-16
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering
Job Description & How to Apply Below
Overview
This is a hands-on, onsite role focused on equipment installation, IQ/OQ execution, and validation documentation within a regulated manufacturing environment (ISO 9001 / ISO 13485). The team is looking for someone who can support qualification activities as the equipment comes online. The role works directly with the Manufacturing Engineering Manager and is execution-focused — ideal for someone who enjoys being on the floor, owning validation deliverables, and supporting equipment readiness in a fast-paced environment.
Responsibilities- Support qualification activities as equipment comes online.
- Perform equipment installation, IQ/OQ execution, and compile validation documentation.
- Work collaboratively with Manufacturing Engineering Manager to ensure equipment readiness in a fast-paced environment.
- Strong focus on IQ and OQ (no PQ ownership).
- Regulated manufacturing experience required (medical device strongly preferred).
- Exposure to tube drawing, metal processing, or Nitinol is a plus, but not required.
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