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Katalyst Healthcares & Life Sciences | Round Lake, Illinois, United States | Posted May 10, 2026
Position Overview
Job Summary:
- Lab Equipment Validation Engineer responsible for leading validation activities for laboratory equipment supporting infusion system testing in a regulated medical device environment, ensuring compliance with FDA regulations, ISO standards, and quality system requirements.
Roles & Responsibilities:
- Lead validation efforts for laboratory equipment supporting infusion system testing (e.g., Infuscale, altitude chambers, environmental chambers, flow measurement instruments, and related test systems).
- Develop and execute validation protocols, test plans, and reports in alignment with FDA 21 CFR Part 820, Part 11, ISO 13485, and equipment validation best practices.
- Partner with R&D, Quality, and Systems Engineering teams to define equipment validation requirements and risk based stra...