CLEANING VALIDATIONLIMERICK

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INDEPENDENT SOLUTIONS

  • Limerick
  • Dublin
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  • Job reference number:15321135
  • Client ID:RI/2018020R
  • Posted on:08-FEB-2018
  • Salary:Competitive
  • Location:LIMERICK
  • Job type:CONTRACT

SUMMARY/POSITION OBJECTIVE:

Completes docuementation for execution of cleaning validation quailifcations studies and investigations. Document Preparation and report generation for activities for the Cleaning Validation Program at the Regeneron Limerick BioTech facility. Team Member positions to be filled in the following areas:

  • Cleaning Validation
JOB DUTIES:

  • Taking Cleaning Validation samples alongside Upstream/Downstream processing.
  • Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
  • Shows focus & a consistence approach to the role and tasks.
  • Excellent people skills
  • Experience in aseptic technique
  • Experience in Gowning for IOS7/ISO8
  • Generating and Executing Validation Protocols.
    • Actively look for Continuous improvements
    • Experience in Validation specifically cleaning validation
    • Experience in assessment of cleaning issues during study runs,
    • Experienced Technical writer,
    • Experience in Deviation/Change control writing,
    • Capable of managing a large program, so project management skills would be necessary,
    • An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works
    • Understanding of baseline studies for new equipment
    • Experienced in coverage testing and clean-into-service
    • Generate/review/Approval of CV protocols,
    • Generate Reports
    • Maintain and update Cleaning Validation Plan
    • Schedule of cleaning activities with Manufacturing
  • Liaise with numerous departments
  • Ensure Training is maintained and current.
  • Follow all EHS/Safety SOP/Policies

JOB REQUIREMENTS: Skills and abilities required to perform the job.

    • Proven Biotech experience in the given area, as follows:
      • Validation engineer position : 3-5 years Biotech cleaning validation experience
    • Experience in Document Preparation and Execution
    • Experience in major start-ups where clean-into-service, coverage testing, baseline studies in commissioning area, and cleaning validation studies may be concurrent activities in different trains.
    • Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing.
  • Have Troubleshooting and analytical mindset.

Minimum Years of Experience: 3-5 years

Minimal educational requirements: B.Sc, B.Eng.

This job originally appeared on RecruitIreland.com