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 ApprovalExperience with Emerson Delta other DCS System PLC SCADADevelop 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 AssessmentsReview and Approval of Automation DesignsInstallation and Operation Qualification (IOQ) Protocol Generation Execution and Reporting for DeltaV (PAS) PLCs Honeywell (QBAS/NQBAS) MESTest specification pre-approval review and post approval prior to progression to IOQ- Change Control Impact AssessmentsMaintenance Review and Approval of site Quality documentation e.g. SLIA CLIA SystemEssential CriteriaBS 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 essentialCandidates will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.iRCAS Communication SkillsMust be available to work minimum 3 days per week onsite.
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