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Cleaning Validation Engineer

  1. Dublin
  1. Contract
  1. Commisions, Qualification and Validation
Date Posted01 May 2020
Cleaning Validation Engineer, Drug Substance Facility, 6 month contract, Ireland 

Our Dublin based partner is looking to Commission Drug Substance Facility, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world. You would be working in a Quality team assisting with Cleaning Validation activities. 

Your responsibilities will include: 
  • Act as Quality Assurance approver for qualification/validation lifecycle documents.
  • Serve as a quality assurance resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
  • Will serve as the Quality SME for all validation activities across the site including but not limited to Steam in Place(SIP), Cleaning Validation & CTU (Controlled temperature Unit) Performance qualification.
  • Provide Quality Assurance Validation support for Steam In Place (SIP) of buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains & Autoclave loads.
  • Provide Quality Assurance Validation support for the Cleaning Validation Program. Cleaning (CIP) cycles/ for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
Please apply for full details .

The candidate must have the rights to work in the location stated in the job advert.

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