Katalyst CRO

Process Validation Engineer

Danvers, MA, US

15 days ago
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Summary

Roles & Responsibilities

  • Process Validation (IQ/OQ/PQ).
  • Product development experience.
  • Process development.
  • Process Layout, Modeling, and Documentation.
  • Equipment and Tooling Development.
  • Process Development and Characterization.
  • Test Method Development and Validation.
  • Developing / Updating MPIs.
  • Supplier Development and Component Engineering.
  • Manufacturing Engineering Support / Engineering Documentation.
  • Update work instructions to match the practice on the floor to what's in the procedure.
  • Create part numbers for some of the machine spare parts and supply items.
  • Update the tooling / fixture drawings to reflect what is used in the production floor.
  • Injection Molding Expertise necessary.
  • Experience with molding, extrusion, tooling, and automation.
  • Experience with measurement systems and inspection systems.

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