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QA Validation Engineer

4 weeks ago

Limerick, Limerick, Ireland TN Ireland Full time

PE Global is currently recruiting for numerous QA Cleaning Validation Engineers on behalf of a leading biotech company based in Limerick. This is an initial 12 month contract role.

Responsibilities:

  1. Execution of cleaning validation protocols.
  2. Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
  3. Generate/review/approval of CV protocols.
  4. Generate reports.
  5. Maintain and update Cleaning Validation Plan.
  6. Schedule cleaning activities with Manufacturing.
  7. Liaise with numerous departments.
  8. Ensure training is maintained and current.
  9. Follow all EHS/Safety SOP/Policies.
  10. Actively look for continuous improvements.

Experience:

  1. Experienced in QA Validation activities.
  2. Extensive experience in writing and approving deviations/GMP documents.
  3. Technical writing experience in writing site reports.
  4. Experience in aseptic technique.
  5. Experience in gowning for ISO7/ISO8.
  6. Generating and executing validation protocols.
  7. Experience in validation, specifically cleaning validation.
  8. Experience in assessment of cleaning issues during study runs.
  9. Experienced technical writer.
  10. Experience in deviation/change control writing.
  11. Experienced in coverage testing and clean-into-service.

Please note that if you are NOT a passport holder of the country for the vacancy, you might need a work permit.

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