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Cleaning Validation - SIP Specialist

Limerick, Limerick City and County Council
18/07/2019 (11:53)
Headcount Solutions Limited
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Cleaning Validation - SIP Specialist

A Cleaning Validation Specialist with strong Steam In Place experience is required for a Munster based Biopharmaceutical multinational.  The successful candidate will complete document preparation and field execution activities for the Cleaning Validation Program at the BioTech facility

Key Responsibilities:

  • Experience in Validation specifically cleaning validation and thermal mapping
  • Experience in assessment of cleaning issues during study runs,
  • Placement of thermocouple probes in vessel and transfer lines
  • 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/ Thermal mapping works
  • Troubleshooting of thermal mapping studies for investigation and Engineering studies
  • Understanding of baseline studies for new equipment
  • Experienced in coverage testing and clean-into-service
  • Generate/review/Approval of CV/ SIP protocols,
  • Generate Reports
  • Maintain and update Cleaning/ Steam in place Validation Plan
  • Schedule of cleaning/SIP activities with Manufacturing

Qualifications and Experience:

  • Proven Biotech experience in the given area, as follows:
  • 3-5 years Biotech cleaning/SIP 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 and SIP 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.
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