Role Title: ManufacturingProjectSupportScientist
Role Type: 12MonthContract
Location: Dublin15
WearecurrentlyworkingwithaBiopharmaceuticalManufacturerinDublin15whoareseekingtorecruitacontractManufacturingSupportScientist/Engineer,reportingintotheAssociateDirectorfornewproductintroductionwithintheManufacturinggroup.
Responsibilities
Contributestocrossfunctionalteam(Manufacturing,Engineering,QA,QC,Regulatory,SupplyChain,etc.)forprocessimprovementimplementations,newproductstart-upsorotherprocesschanges.
Supportnewproductintroductionriskassessmentstoensuretheappropriatecontrolsareinplacetoenablemanufacturing.
Supportproductchangeoverprotocolstoallowasmoothtransitionfromsustainingtonewproductmanufacturing.
RepresenttheManufacturingatmeetingtoensuretheenduserrequirementsarerepresented
Supportsprocesstechnologytransfer,andthepreparationofmanufacturingdocumentationfordevelopment,engineeringandPPQbatches.
IdentifyprocessimprovementprojectsforNewProductIntroductionandsupportprojectstocompletion.
Workwithsustainingteamtounderstandingcurrentissuesandensureimpactofnewproductsaredefined,agreedandunderstood.
Writeprocessimpactassessmentstosupportnewproductintroduction.
ProvideSMEinputintocross-functionalteamsinvestigating&optimizingnewmanufacturingprocesses,proceduresanddocumentation.
ProvidetrainingtoBPAsonnewprocedures.
Supportexternalandinternalaudits.
Workwithcross-functionalteamsontheintroductionofconsumablesandrawmaterialstosupportNewProductIntroduction.
Worktoimplementa“Right-FirstTimeCulture”andprovideleadershipintheuseofOEprinciples.
Supportthedispositionprocesswhenrequired
Carryoutorganizationalactivitiessuchaspurchasing&co-coordinatingcommunicationinformation.
Own&drivechangecontrols,CAPA’s,investigations,improvementprojectsandoperationalsafety.
Minimizehumanerrorandworkwithoperationstoremovesourcesoferror.
DepartmentalApproverofoperationsprocedures,electronicbatchrecordsandotherGMPdocumentationandprovidetechnicaltrainingandknowledgetransfertotheOperationsteam.
Supportsustainingoperationswhenrequiredtoensureproductsupply
DevelopstrongworkingrelationshipswithQuality,Engineering,TechnicalServices,SupplyChain,RegulatoryAffairs,HumanResources,Finance.
SupportandimplementnewtechnologysolutionssuchasSingle-Usetechnology.
Qualifications and Experience required
3-4yearsexperienceinUpstreamorDownstreamManufacturing.
Bachelors/MastersinScience,Engineering,orarelatedsubject.
IndepththeoreticalknowledgeofGMPbiologicsmanufacturingequipmentandprocessautomation.
Provenabilitytosupportthecloseoutofcomplextechnicalinvestigations.
StrongworkingknowledgeofsystemssuchasDeltaV,MESSyncadeandSAP.
Excellentpresentationskills.
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