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Validation Engineer
Katalyst Healthcares & Life Sciences • Cambridge, Massachusetts, United States
About the Role
Roles & Responsibilities:
- We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments.
- Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5.
- A solid working knowledge of regulatory frameworks is essential specifically ISO 13485, ISO 14971, EU IVDR 2017/746, and FDA 21 CFR 820 along with demonstrated ability to develop and maintain Master Validation Plans, define CTQ-based acceptance criteria, and establish traceability across risk controls, process parameters, and validation outputs.
- Experience with PFMEA and change control impact assessments is also expected.
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