Laboratory Equipment Qualification Specialist - New Build Biologics
2d ago

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!

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

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