Overview

Senior Process Engineer-1-POS_75091210-1DescriptionSanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.Sanofi USAt Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health.Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company dedicated to discovering, developing and distributing therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi US employs approximately 17,000 people across the country all dedicated to protecting health, enhancing life and responding to the hopes and potential healthcare needs of seven billion people around the world.Commitment is our Strength. Ready to grow together?Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-800-207-8049 Option 7, then Option 3.Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.SENIOR PROCESS ENGINEERDEPARTMENTDESCRIPTIONTheEngineeringGroupat the FraminghamBiologicsmanufacturingsitesisresponsibletoensurethatthemanufacturingequipment/systemsusedinthemanufactureandstorageof Sanofi Genzymeproductsaresafeandfitforpurposeinaccordancewith Sanofi GenzymeCorporatestandardsandindustryregulatoryrequirements.Thisencompassesworkprocessesthatoriginatewiththeidentificationofneworrevisedassets;thedesign,installation,verificationandvalidationoftheassets;themaintenanceoftheassetsintheir commissioned/qualified/validatedstates;andtheretirementoftheassetsattheendoftheirlife.POSITIONOVERVIEW / KEYRESPONSIBILITIESPositionSummaryThisposition,withminimalguidance,leadstheengineeringsupportofmanufacturing,maintenanceandcapitalprojects.This position develops,organizes,analyzesandpresentsinterpretationofresultsforoperationalissuesorconcurrentengineeringprojectsofmoderatescopeandcomplexity.CoreResponsibilities· Executeconcurrentprojectsofmoderatescopeandcomplexity,withminimalsupervision.· Interpretandexecutepoliciesandprocedures.Recommendmodificationstooperatingpolicies.· Leadasmallgroupofengineersand/ortechniciansonanongoingorprojectbasis.· Activelyparticipateandprovideinputandfeedbackforthe Sanofi GenzymeSafetyProgramtomeetHealthandSafetyregulationsandOSHArequirementsinallduties.· Functionasatechnicalexpertonequipmentorsystems;leadtroubleshootingofoperations,developpreventativemaintenanceprocedures,andmaintainengineeringdocumentation.· Routinelyaudittheoperationalperformanceandregulatorycomplianceofalargenumberofhighlycomplexequipmentcomponentsorsystems.· Leadeffortswithmanufacturing,processdevelopment,facilities,qualityassuranceandotherdepartmentsindevelopingrequirementsandrecommendationsforsystemmodifications.· Executetasks,undertheminimaldirectionofprojectmanagers,tocompletedesign,engineering,construction,commissioning,andqualificationforprojectswithinscheduleandbudgetconstraints.· Coordinatetheworkofconsultantsandengineeringfirmsondevelopmentofstandarddesigndocuments.· Developprojectscopes,schedulesandbudgets.· Obtainandcritiquequotesforsystem/facilitymodifications andworkwithvendorstoexecute.· Leadinitiativesand/orprojects.· Demonstrateskillsinthefollowingareas:o Scheduledevelopmento Facilitationo Collaborationo Basicprojectmanagemento Completionandfollow-up· Utilizequalitysystemstoensurecompliancewithregulatoryrequirements.· Partnerwithpeers,teammembers,directandindirectmanagementchaintoensurethefollowing:o Trainingplanexecutiono EnsureInspectionReadinessofassignedareaso Participateintimelycompletionofinvestigations,deviationsandCAPAo Providesupportfordocumentationchangeso Developandmanagechangecontrols· Complywithrequirementsfrom Sanofi Genzyme’sSafetyProgramincludingHealthandSafetyregulationsandOSHArequirements. #LI-GZQualificationsLEADERSHIPQUALIFICATIONSDemonstrate anongoingcommitmenttoconductingourglobalbusinessaccordingtothehighestlegalandethicalstandards,andtocontinuallypursueexcellenceinthedevelopmentanddeliveryofallofourproductsandservices.Thisincludes:· Adheringtoallapplicablelawsandregulationsoftheplacesinwhichweconductbusiness,aswellasourownCompanypoliciesandprocedures.· Beinghonestandtreatingpeoplewithrespectandcourtesy.· Constantlystrivingtomake Sanofi Genzymeagreatplacetowork,andacompanyrespectedforthequalityofitspeopleandproducts.· Actingasrolemodelsforourfellowemployeesbyactingresponsibly,fairly,andhonestlyinourdealingsandexercisingsoundjudgmentinperformingourjobs.BASIC QUALIFICATIONSBachelor’s degree in Engineering with 8+ years of relevant work experience including 5+ years of experience in Bio-Pharmaceuticals; or Master’s with 5+ years of experience in Bio-Pharmaceuticals.· Directexperiencewithregulatedenvironments(i.e.cGMP,OSHA,EPA).· GeneralunderstandingofQualitySystems.· Generalunderstandingandwideapplicationoftechnicalprinciple,theories,andconceptsintheBiotech/Pharmaceuticalfield.· Generalknowledgeofotherrelateddisciplines.· Demonstratedskillsinthefollowingareas:o Problemsolvingandappliedengineeringo Basictechnicalreportwritingo CommunicationPREFFERED QUALIFICATIONS· Workingknowledgeofpharmaceutical/biotechprocesses.· Workingknowledgeofspecializedequipment/processes.· GeneralknowledgeofCommissioningandQualification.· Effectivelyinteractwithavarietyofcommunicationandworkingstyles.· Abilitytoindependentlydeterminewhenadditionalinternal/externalresourcesarerequiredtosolveproblems.SPECIAL WORKINGCONDITIONS· Abilitytogownandgainentrytomanufacturingareas.· Requiredtosupportmanufacturingoperationsonan“oncall”24/7basis.Job:Engineering & MaintenancePrimary Location:United States-Massachusetts-FraminghamJob Posting:Sep 6, 2016, 10:13:38 AMJob Type:RegularEmployee Status:Regular