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CSV Engineer

CSV Engineer

Job description

I am currently recruiting a CSV engineer to join a leading Cork based pharmaceutical on a contract basis. This is initially a 12-18 month contract but will be moving into a permanent position, if that is what the candidate wants. There is a very attractive hourly rate on offer, and this is not an opportunity to be missed.

Responsibilities include but are not limited to:

  • Automation Change (IRIS) Review and Approval
  • Experience with Emerson Delta other DCS System PLC SCADA
  • Develop and complete continuous improvements as part of the validation team- Co-ordination of changes to ensure timely delivery.
  • CSV Deliverables including 21CFR11 Assessments Annex 11 Assessments Business Criticality Assessments GAMP Assessments
  • Review and Approval of Automation Designs
  • Installation and Operation Qualification (IOQ) Protocol Generation Execution and Reporting for DeltaV (PAS) PLCs Honeywell (QBAS/NQBAS) MES
  • Test specification pre-approval review and post approval prior to progression to IOQ- Change Control Impact Assessments
  • Maintenance Review and Approval of site Quality documentation e.g. SLIA CLIA System

Essential Criteria

  • BS in Engineering, Computer Science, Science or other technical degree.
  • 2-5 years’ experience of working in a pharmaceutical API manufacturing operation is desirable.
  • Experience with Labware any LIMS essential
  • Candidates will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
  • iRCAS Communication Skills
  • Must be available to work minimum 3 days per week onsite.