Computer Systems Validation Engineer – CSV Engineer

We are looking for experienced CSV Engineers for existing and new projects in Dublin, Cork and Waterford.

Role/Opportunity

  • Support department activities, including but not limited to the preparation of Validation/Qualification plans, risk assessments, URS, Traceability Matrix, testing, data migration, SOPs and Change Controls.
  • Ensure that the computerised systems are in full compliance with both regulatory requirements and with company policies and procedures.
  • Support the resolution of deviations and/or errors and provide quality guidance on GxP regulatory requirements

Experience/Background

  • 3rd level Science / Engineering degree required.
  • Minimum of 3 years relevant CSV experience in either the Pharma or Biotech industry.
  • Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11 is required.
  • Strong knowledge of computerised system development life cycle.
  • Experience of coordination of Quality documentation and in particular qualification/validation documentation.
  • Validation experience with ERP, MES, DCS, LIMS, PLC and Quality Systems
  • Ability to present validation documentation during the IMB, FDA and Corporate audits

Contact us to discuss this opportunity further.

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