Katalyst CRO

Validation Engineer

Raynham, MA, US

3 months ago
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Summary

Responsibilities

  • Ask candidates if they have validated equipment and what type of equipment they have validated.
  • Mechanical/manufacturing experience.
  • Writing and executing validation protocols.
  • CSV is nice to have, but if the candidate has done that exclusively it will not work.

Requirements:

  • A minimum of a Bachelor's degree in Engineering is required.
  • Minimum of 1-3 years' experience in medical device manufacturing, Bio/pharma is also good
  • Develop and implement processes to support the production of Orthopedic implants.
  • Experience with metal finishing processes required.
  • Experience with Change Control Validation in a regulated environment (medical device).
  • IQ/OQ/PQ Experience.
  • Equipment Validation/Machine Validation Experience.
  • Experience in technical writing.
  • Experience with Data and statistical analysis.

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