Commissioning Engineer

PEGlobaliscurrentlyrecruitingforaCommissioningEngineerforaleadingmulti-nationalPharmaclientbasedinSouthDublin. Thisisacontractposition. RoleOverview : WeareseekingacontractCQVEngineerwithprovenexperienceincommissioningandqualificationofequipmentandutilitiesinadrugsubstance(DS)manufacturingenvironment.Thesuccessfulcontractorwillplayacriticalroleindeliveringafast-pacedCQVprograminlinewithGMP,projecttimelines,andregulatoryexpectations. Youllbeexpectedtoworkindependentlyoraspartofacross-functionalCQVteamtoauthorandexecutequalificationprotocols,managedeviations,andsupportsystemhandoverforGMPoperations. KeyResponsibilities : Deliverend-to-endCQVlifecycledocumentation : URS,DQs,FAT / SAT,IQ,OQ,andsupportforPQwhereapplicable. Performequipmentandsystemcommissioning,includingverificationofinstallation,utilitiesintegration,controlfunctionality,andsafetysystems. LeadCQVeffortsonsystemsincluding(butnotlimitedto) : -Bioreactorsandsingle-usetechnologies -ChromatographyColumns -Clean-in-place(CIP)andsteam-in-place(SIP)systems -WFI,cleansteam,andprocessgases -Processtanks,skids,andassociatedpiping Conductimpactassessments,riskassessments(e.g.ASTME2500),anddefineappropriatequalificationstrategies. Liaisewithvendors,automation,engineering,andqualityfunctionstocoordinateexecutionandresolveissues. Supportandleadtheresolutionofdeviations,non-conformances,andchangecontrolsrelatedtoCQVscope. Maintainup-to-dateandcompliantdocumentationinlinewithGMPanddataintegrityrequirements. Provideprogressupdatesandcontributetosystemreadinessreviewsandhandovermilestones. Experience : BachelorsdegreeinEngineering,LifeSciences,orrelatedtechnicalfield. Minimum5yearsCQVexperienceinaGMP-regulateddrugsubstanceorbiologicsmanufacturingenvironment. Demonstratedhands-onexperiencewithcommissioningandqualificationof : -Large-scalebioprocessequipment -Utilitysystems(WFI,HVAC,compressedgases,cleansteam) -Automation-integratedequipment(DeltaV) DeepunderstandingofCQVbestpractices,ISPEBaselineGuides,GAMP5,andASTME2500. Experienceworkingoncapitalprojects,preferablyfromconstructiontohandover. Abilitytoworkindependentlyonprotocoldevelopment,execution,andresolutionmanagement. InterestedcandidatesshouldsubmitanupdatedCV. Pleaseclickthelinkbelowtoapply,oralternativelysendanuptodateCVto

• PleasenoteourclientcannotassistwithanyvisasponsorshipandcandidatesmusthavethecorrectvisatoliveandworkinIreland
• Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills : CQV Thermal mapping