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CSV Engineer

Job description

Job Responsibilities 

  • The CSV Engineer will support management of CSV re-qualification in a first of its kind facility in Ireland
  • Support the CSV requirements for site production and laboratory systems.
  • Provide CAPEX team with adequate validation support at all times.
  • Review vendor documents to support commissioning and qualification requirements.
  • The CSV Engineer will complete the development, review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
  • Ensures validation non-conformances or deviations are minimised during execution of CSV activities. For issues that do arise ensure they are closed out in a timely manner.
  • You will also support Technology Transfer initiatives for new incoming biologics products 

Job Requirements

The next CSV Engineer should have a degree in Science or Engineering with at least 3 years CSV experience. 

You should have a strong working knowledge of validation practices including 21CFR Part 11 requirements, ER/ES and data integrity guidelines 

If you're looking to work with an innovative biopharma client in a first of its kind facility in Ireland then get in touch now!

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