Validation Engineer

Katalyst Healthcares and Life Sciences

Cambridge, MA

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.
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.
On the analytical side, candidates should be proficient in statistical methods used in validation, including Measurement System Analysis (MSA), process capability analysis, and sampling plan design.
Familiarity with CLSI guidelines and ISO 15189 for analytical/diagnostic method validation is a plus given the IVD product focus.
Strong technical writing skills are a must - this person will be authoring protocols, deviation reports, and validation summaries that must hold up to regulatory scrutiny.
Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs, and IT is a core part of the day-to-day, so candidates should be comfortable driving validation workstreams independently across multiple concurrent projects.

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Vacancy posted 5 days ago

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