Job Description


Job Summary:

  • The Process Validation Engineer supports medical device manufacturing by developing, executing, and maintaining validated manufacturing and test processes.
  • The role ensures compliance with FDA QSR ( CFR ), ISO , and cGMP requirements while collaborating cross-functionally to improve process capability, quality, and efficiency across a variety of manufacturing operations.

    • Roles & Responsibilities:
  • Develop and execute process validation strategies, including process characterization and creation of IQ, OQ, and PQ protocols and reports.
  • Perform equipment IQ/OQ, process OQ/PQ, test method validation, and Gage R&R studies.
  • Ensure regulatory compliance with FDA QSR, ISO , and internal quality system requirements; participate in audits as needed.
  • Compile, analyze, and interpret validation and SPC data; identify trends and opportunities for continuous improvement.
  • Le...

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