Senior SAP PM and Calibration Consultant

JobDescription:SeniorSAPPMandCalibrationConsultant

• Location:Somerset,NewJersey(NJ)

• Duration:6Months

• GBaMSReqID:11014830

• ExperienceRequired:8–10Years

• Role:SeniorConsultant–SAPPMandCalibration

• Industry:MedicalDeviceManufacturing/RegulatedEnvironment

RequiredTechnicalSkills

• 7–10yearsofexperienceinSAPPlantMaintenance(PM)andCalibration.

• Proventrackrecordofdelivering2–3full-lifecycle,validatedSAPimplementations.

• Stronghands-onexperiencewithSAPS/4HANA.

• ExpertiseinSAPPlantMaintenanceandQualityManagement(QM)integration.

• Experienceconfiguringcorrective,preventive,andhigh-prioritybreakdownmaintenanceprocesses.

• StrongknowledgeofSAPPMmasterdataandconfiguration,including:

  • FunctionalLocationHierarchies

  • EquipmentMasterRecords

  • MaintenanceNotifications

  • MaintenanceWorkOrders

  • TaskLists

  • EquipmentBillsofMaterials(BOMs)

• Experiencewithcalibration-specificdata,includingMasterInspectionCharacteristics(MICs)andsamplingprocedures.

• Strongunderstandingofregulatorycompliance,GxPstandards,andComputerSystemValidation(CSV).

• ExperienceintegratingSAPPMwithMaterialsManagement(MM),ProductionPlanning(PP),andFinance.

• KnowledgeofSAPintegrationtechnologies,includingSAPBTP,SAPPI/PO,IDocs,andAPIs.

• Experienceintegratingthird-partymetrologysoftware,calibrationbolt-onsystems,mobilemaintenancetools,andasset-trackingsystems.

RolesandResponsibilities

1.SAPPMandCalibrationImplementation

• Leadend-to-enddesign,configuration,anddeploymentofSAPS/4HANAPlantMaintenanceandCalibrationsolutions.

• Architectandmanagecorrective,preventive,andbreakdownmaintenanceworkflows.

• DesignandconfigureintegratedcalibrationprocessesconnectingSAPPlantMaintenancewithQualityManagement.

• Configureandmaintainfunctionallocations,equipmentmasters,notifications,workorders,tasklists,andequipmentBOMs.

• Configurecalibration-relatedMasterInspectionCharacteristics,samplingprocedures,andinspectionprocesses.

• Ensureseamlessexecutionofmaintenanceandcalibrationactivitiesacrossmanufacturingoperations.

2.RegulatoryComplianceandValidation

• EnsureSAPsolutionscomplywithGxPrequirementsandapplicableregulatorystandards.

• SupportComputerSystemValidation(CSV)activitiesthroughoutimplementationanddeployment.

• Maintainrobustaudittrails,dataintegrity,andend-to-endtraceability.

• Ensuremaintenanceandcalibrationworkflowsmeetmedicaldevicemanufacturingcompliancerequirements.

• Supportcomplianceauditsandprovidedocumentationdemonstratingprocesstraceabilityandsystemvalidation.

• EnsureexternalsysteminterfacescomplywithGxPandCSVrequirements.

3.IntegrationandTechnicalArchitecture

• DesignandimplementinterfacesbetweenSAPandthird-partymetrologysoftwareandcalibrationsystems.

• SynchronizeMasterInspectionCharacteristics,calibrationtestresults,andequipment/devicestatusesacrossconnectedsystems.

• UseSAPBTP,SAPPI/PO,IDocs,andAPIstoenablesecureandreliableintegrations.

• Integratemobilemaintenanceapplicationsandasset-trackingsystemswithSAP.

• CoordinateintegrationswithSAPMM,PP,QM,andFinancemodules.

• Maintaindataconsistency,systemreliability,andauditabilityacrossintegratedapplications.

4.BusinessProcessDesignandStakeholderManagement

• Conductrequirements-gatheringanddesignworkshopswithmaintenance,qualityassurance,andlaboratoryteams.

• TranslatebusinessrequirementsintofunctionalspecificationsandSAPconfigurationdesigns.

• Bridgetechnicalimplementationactivitieswithbusinessandoperationalneeds.

• Coordinatewithcross-functionalteamstoresolveintegrationandprocessissues.

• Supporttesting,validation,deployment,andpost-implementationactivities.

• Ensurethedeliveredsolutionalignswithbusinessobjectivesandregulatoryexpectations.

DesirableSkills

• Experienceinmedicaldevicemanufacturingorpharmaceuticalmanufacturing.

• ExpertiseinvalidatedSAPimplementationswithinregulatedenvironments.

• Knowledgeofthird-partycalibrationandmetrologyapplications.

• ExperiencewithSAPS/4HANAintegrationsandmiddlewaretechnologies.

• Strongunderstandingofassetmanagement,equipmentlifecyclemanagement,andcalibrationtraceability.

KeySkillsSummary

• SAPPlantMaintenance(PM)

• SAPCalibration

• SAPS/4HANA

• SAPQualityManagement(QM)

• SAPMM,PP,andFinanceIntegration

• CorrectiveandPreventiveMaintenance

• BreakdownMaintenance

• EquipmentMasterDataandFunctionalLocations

• MaintenanceWorkOrdersandTaskLists

• EquipmentBillsofMaterials

• MasterInspectionCharacteristics(MICs)

• GxPCompliance

• ComputerSystemValidation(CSV)

• AuditTrailsandDataIntegrity

• SAPBTPandSAPPI/PO

• IDocsandAPIs

• Third-PartyMetrologyandCalibrationIntegration

• MedicalDeviceManufacturing