CSV Analyst - Lab Equipment - New Build Biologics
1d ago

New Build biologics facility have a contract requirement for an experienced CSV Analyst to assist with the computer system validation of the new Laboratory (analytical) equipment & system implementation programme.

Working within a new state of the art Biologics facility manufacturing you will be required to work as part of a team to assist with the CSV of 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 :

  • Prepare CSV documentation for all global systems
  • To prepare plans and protocols for CSV; Apply GAMP5 and ASTM2500 principles to project CSV
  • Prepare Risk Assessments and quality assessments as required
  • Provide guidance and technical skill knowledge to the site relating to automation System Life Cycle and computer system validation concepts
  • Implementation of a CSV system to support new systems / equipment and upgrade leveraged systems / equipment
  • Responsible for authoring, review, and / or approval of departmental Standard Operating Procedures (SOPs) specific to computer system validation activities
  • Co-ordinates and manages all aspects of computer system validation projects, including the resolution or escalation of project-specific issues
  • Ensures systems are in compliance with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, as well as requirements from EU Annex 11 and all Data Integrity standards and guidelines.
  • To be successful for this role we require the following :

  • Degree qualified
  • Experience of either biotechnology or pharmaceutical industry
  • Prior AIQ analytical instrumentation experience within a Pharma / Bio environment
  • Experience with GAMP5 & ASTME2500
  • 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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