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Sr. Manufacturing Engineer
Job in
Warsaw, Kosciusko County, Indiana, 46580, USA
Listed on 2025-12-16
Listing for:
Katalyst CRO
Full Time
position Listed on 2025-12-16
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer -
Manufacturing / Production
Quality Engineering, Manufacturing Engineer
Job Description & How to Apply Below
Summary
We're looking for a Sr. Manufacturing Engineer to lead and execute CNC equipment/process validation in a regulated Med Tech environment. If you have hands‑on experience with IQ/OQ/PQ, calibration, and process capability, this is a strong opportunity.
Roles And Responsibilities- Lead validation for CNC machines (mills, lathes, multi‑axis) and tooling/work holding.
- Author and maintain IQ/OQ/PQ protocols & reports + validation documentation.
- Support Master Validation Plans, FMEA/risk assessments, and change controls.
- Execute calibration, metrology, and Gage R&R; ensure full traceability.
- Perform data analysis and capability studies (Cp/Cpk, Minitab/JMP).
- Close deviations, support CAPAs/nonconformances, and maintain audit readiness.
- Support supplier qualification/acceptance testing and operator training.
- BS in Mechanical/Manufacturing/Biomedical Engineering (or related).
- 3-7 years in CNC manufacturing + validation in regulated environments.
- Strong knowledge of ISO 13485, GMP, 21 CFR Part 820 (ISO 14971 preferred).
- Experience with eQMS tools (e.g., Master Control, ETQ).
Mid‑Senior level
Employment TypeContract
IndustryPharmaceutical Manufacturing
Location & CompensationElkhart County, IN – $110,000 – $130,000
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