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Clean Hold Executor

  1. West
County Limerick
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
10-05-2021
26795/NK

This vacancy has now expired

Cleana Hold Executor - Biotech - 12-month contract - Ireland 

Clean Hold Executor required to work for a Biotech Manufacturing facility in Munster. We are looking for somone with Cleaning Validation Experience to work 45 hours per week Monday-Friday on site in County Limerick. 

The ideal candidate will have expertise in: 
  • Experienced in QA Validation activities  
  • Execution of clean hold protocols.
  • Experience on writing and approving Deviations/ GMP documents
  • Technical writing experience in writing site reports.

Duties to include (but not limited to): 
  • Taking Clean hold rinse and swab samples on process equipment and small parts
  • Working closely with manufacturing to ensure the CIP/SIP and holds are achieved and samples are taken.
  • Working with engineering to determine flow paths for rinse samples and surface area calculations
  • Shows focus & a consistence approach to the role and tasks.
  • Excellent people skills
  • Experience in aseptic technique
  • Experience in Gowning for ISO8
  • Generating and Executing Validation Protocols.
  • Actively look for Continuous improvements
  • Experience in Validation specifically cleaning/ clean validation
  • Experience in assessment of cleaning issues during study runs,
  • Experienced Technical writer,
  • Experience in Deviation/Change control writing,
  • An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works
  • Generate/review/Approval of CV protocols,
  • Generate Reports
  • Maintain and update project Cleaning Validation Plans as required
  • Schedule of clean hold activities with Manufacturing
  • Liaise with numerous departments
  • Ensure Training is maintained and current.
  • Follow all EHS/Safety SOP/Policies

For more information on this position, please apply with a copy of your up to date CV today!

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

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