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Process Engineer II

1 month ago

Fort Worth, Texas, United States Smith & Nephew Full time

h2JobSummary/h2pSmith+NephewisseekingahighlyskilledProcessEngineerIItosupportProductLifecycleManagementfortheFortWorth-Vickerysite.Asakeymemberofourteam,youwillberesponsibleforallaspectsofdifferentmanufacturingprocesses,includingTechnologyTransfer,processownerduringcommercialmanufacturing,processimprovements,processandmaterialcharacterization,validationactivities,andmore./ph2KeyResponsibilities/h2ulliSupportProductLifecycleManagementfortheFortWorth-Vickerysite/liliResponsibleforallaspectsofdifferentmanufacturingprocesses/liliContributetotheauthorshipofand/orownerofManufacturingBatchRecords,ProcessSOPs,ProcessValidationProtocolsandReports,QualityControlmethodtransfers,ProcessCharacterizationSummaryReports,RegulatoryAffairsfiling/datacollectionandanyprocessrelatedcompliancedocuments/liliDirectlyinvolvedwiththecommissioningofanynewmanufacturingequipmentmonitoringandalarmsystems,orexecutionofvalidationprotocolsintheclean-roomsasrequested/liliReviewand/orapprovalofManufacturingChangeControls,Validationprotocols,andCAPAs/liliInvestigateorprovideoversightforanydeviationswithpotentialforproductimpact/liliImplementCAPAs,ChangeControlsasneeded/liliLeadriskassessmentstosupportanyobservationresponses,CAPAs,etc./liliIdentifyandimplementprocessimprovement/scale-up/processefficiencychangecontrolsandassociateddevelopment/testprotocols/liliConductStabilitystudiesandtemperaturecontrolexperimentstosubstantiateand/orproducedatatosupporttemperatureandstorageconditionlabeling/liliEnsurecompliancewithSiteValidationMasterPlanbycoordinatingallactivitiessuchascleaningvalidation/monitoring,periodicrequalification/revalidation,and/orperiodicvalidationassessment/liliAnnualstatistics/processcontrolcharting/li/ulh2Requirements/h2ulliBachelorofScienceinEngineering,Biology,orChemicalSciences/liliMinimumof3years'experienceinaPharmaceutical/Biotechenvironmentor2yearsinaProcessEngineerrole/liliKnowledgeincycledevelopmentforautoclaveandCIP/liliProjectManagementexperienceaplus/liliCommunicationsskills,includinginteractionwithdiversefieldssuchasR&D,Engineering,Manufacturing,Quality,RegulatoryAffairs,ProjectManagement,andgeneralmanagement/liliAbilitytoidentifyproblemsandfindsolutions,aswellasexpressthoseproblemsappropriatelytomanagementwhenrequired/liliDigitalliteracyincludingfamiliaritywithMicrosoftWord,PowerPoint,Excel,andAccess/liliAbilitytoworkwithtrendingsoftwaresuchasJMPispreferred/liliReadingcomprehensionandattentiontodetail/liliAbilitytoactindependentlytocarryouttasksgivenbymanagementinthetimeallotted/liliProvenabilitytolearnnewtasksandadapttonewsituations/li/ul