Job Description
CommissioningandQualification(C&Q)engineerforvariouscapitalprojects,ensuringactivitiesarecompletedsafely,onscheduleandincompliancewithGMPandQualityRequirements.bResponsibilities:/bulliCommissioning&QualificationofCleanUtilitySystems/liliGenerationofallC&Qtestdocuments/liliProvidetechnicalassistanceduringinvestigationsandsystemdesign/liliCoordinatesandSupervisesallC&Qactivitiesontheirsystems/liliEnsurestheC&Qscheduleismaintained/liliManagesDailyC&Qcoordinationmeetings/liliResponsibleforTrackingandReportingofC&Qstatusandrisks/issues/liliEnsuresStartupofequipment/utilitiesiscompletedinasafeandcoordinatedmanner/liliAssistinthedevelopmentofUserRequirementSpecifications(URS's)andQualityRiskAssessmentforEquipmentandAutomatedSystems(QRAES)/li/ulbRequirements:/bulli6+yearsexperienceinEngineeringorCommissioningandQualificationManagement/liliTechnicalqualificationatthirdlevelorequivalentinEngineering/liliExtensiveknowledgeanddemonstratedexperiencemanagingCommissioningandQualificationforPharmaceutical/Biotechnologyprojects/liliKnowledgeofsafety,GMPandenvironmentalregulatoryrequirements/liliDemonstratedstrongCommunicationandLeadershipskills/liliDemonstratedabilitytocollaboratewithseniorstakeholderstoachieveoptimaloutcomes/liliStrongunderstandingofarisk-basedapproachtocommissioningandqualificationwithinthebiotechnologyindustry/liliFamiliaritywithpaperlessvalidationsystems/li/ul