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Validation Engineer

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Katalyst HealthCares & Life Sciences
📍 Cambridge, United States
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Location Cambridge
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Posted June 07, 2026
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Commute Local Area
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Job Description


Roles & Responsibilities:
  • We are seeking a seasoned Validation Engineer with + 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 .
  • A solid working knowledge of regulatory frameworks is essential — specifically ISO , ISO , EU IVDR /, and FDA CFR — 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 ...

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    📍 Location Details

    🌆
    City
    Cambridge
    🗺️
    Country
    United States
    🚗
    Commute
    Local Area

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