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Laboratory Equipment Qualification Specialist - New Build Biologics

  1. Dublin
  1. Contract
Competitive
23555WP
  1. Commisions, Qualification and Validation
Date Posted13 Jan 2020

This vacancy has now expired

New Build biologics facility have a contract requirement for an experienced Laboratory Equipment CQV Engineer to work on the qualification of the analytical equipment qualification.  

Working within a new state of the art Biologics facility manufacturing you will be required to work as part of a team to qualify over 200 pieces of new Laboratory equipment on site.

Analytical Laboratory equipment to qualify will include: Chromatography systems, Immuno assay equipment, TOC, FTIR, SpectraMax L & Karl Fischer Units.

Duties will include:

  • You will be involved in the development of the URS's & Risk Assessment documentation and drafts of IQ/OQ/PQ as well as execution 
  • Review and communication of instrument qualification in a concise, organized, and compliant manner
  • Author SOPs and training documents
  • Provide quality oversight and ensuring GMP compliance for engineering and validation deliverables related to site and capital projects (Compliance, Improvement, Technology Transfers, etc.) including requirements definition, specification, engineering design, qualification, process validation and change management
  • Responsible to review and approve validation protocols, reports, procedures and other related documents to ensure compliance 
To be successful for this role we require the following:
  • Degree qualified
  • Experience of either biotechnology or pharmaceutical industry
  • Experience with IOQ protocol generation, review and execution
  • Analytical instrument qualification to include laboratory equipment but not limited Chromatography systems, Immuno assay development, TOC, FTIR etc.
  • To be able to commit to an on-site interview in Dublin 
  • Be available max. of 4-6 weeks notice

Call me for further information on this role!



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