PreviousPharmaceutical/Biotechexperienceismandatoryforthisrole.MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries.ItsservicesincludeEngineering,ProjectManagement,andValidation.MMRConsultinghasofficesinCanada,USA,andAustralia.Thisisanoutstandingopportunitytojoinourgrowingteam,wherethesuccessfulcandidatewillworkwithagroupofengineersinvolvedinthedesign,commissioning&qualification,start-upandprojectmanagementofvariousprocesses,systems,andfacilities.Theidealcandidateshouldpossessleadershipskillstoleadteamsofintermediate&juniorengineers.ThisroleisforC&QManagerwillrequiretoworkonthevalidationofupstreamanddownstreambioprocesssystems/equipmentinthebiopharmaceuticalindustry,aswellasprocessequipmentinpharma/biotechindustries.Theidealcandidateshouldpossessleadershipskillstoleadteamsofintermediate&juniorengineers.The work will require working out of client’s facilities, which are in US (company offers TN Visa sponsorship).Responsibilities- Providetechnicalguidanceintothecommissioning,qualificationandstart-upofvariousequipmentandfacilitiesusedinlifesciencemanufacturing,suchasbioreactors,tanks,CIP,Buffers,Media,Chrom,TFF,washers&autoclaves,etc.- Leadthedevelopmentofkeyqualificationdeliverablesduringtheprojectlifecycletoensureprojectiswelldefined,andtheactionplantotestthesystemisapplicableandrelevant.- LeadqualificationprocessesthroughouttheprojectlifecyclesuchasVPP,RiskAssessments,RTM,DQ,FAT,SAT,IQ,OQandPQasappropriatetoensuretimelycompletionandtoensureallspecificationsaremet.- Prepareprotocols,executeprotocols,summarizedata,resolvedeviations,preparefinalreports.- ExperiencewithC&Qofupstreamordownstreambioprocesssystemsisrequired.ExperiencewithC&Qofotherprocessequipment,utilities,facilitiesisanasset.ThermalValidationexperienceisanasset.- Coordinatemeetingswithcross-functionaldepartments,todriveprojectprogress,facilitatedecisions,provideupdates.- Engageotherdepartments,asrequired,fordesignreviewsanddecisions.- Travelmaybeoccasionallyrequiredformeetingswithclients,equipmentfabricationvendorsorFactoryAcceptanceTesting(FATs).- Workmayrequireoccasionalsupportovershutdownsorextendedhours,specificallyduringinstallationandcommissioning/validationphases.- Client-management(maintainkeyClientrelationshipsinsupportofbusinessdevelopmentandpursuitofnewwork),projectscheduling/budgeting,coordinationofclientandMMRresourcesforeffectiveprojectdelivery,supportingbusinessdevelopment(providingtechnicalsupporttothesalesasrequiredforproposals/opportunities),presentingatindustryconferences/publishingpapersetc.- Visitconstructionandinstallationsitesfollowingallsitesafetyrequirements.- Otherdutiesasassignedbyclient,and/orMMR,basedonworkloadandprojectrequirements.Qualifications- ExcellentwrittenandspokenEnglishisrequiredincludingthepreparationoftechnicaldocumentsinEnglish- Yearsofexperience:8+yearsforyearsofexperienceincommissioning,qualificationorvalidationofvarioussystemswithinthepharmaceutical/biotechindustry.- KnowledgeofrequirementsforacGMPoperations,includingSOPs,ChangeControls,Validation.- Experiencewithdevelopingandexecutingvalidationprojects.Risk-BasedCommissioning&Qualificationapproaches,suchasASTME-2500orISPEICQ,isconsideredanasset,butnotrequired.- Experiencewithcommissioningandqualificationofbiotechprocessequipment(upstreamordownstreamorboth),suchassome,butnotall,ofthefollowing:fermentation,bioreactors,downstreampurificationprocesses(chromatography,TFF,UF)isrequired- Experiencewithcommissioning&qualificationofprocesscontrolsystems(i.E.PCS,SCADA,Historians)andbuildingautomationsystems(i.E.SiemensInsight/Desigo,JCIMetasys)areconsideredanasset,butnotrequired.- ExperiencewithQualificationorValidationofcleanutilities,ISOcleanrooms,andThermalValidationisconsideredanasset.- ExperiencewithpreparationandexecutionofURS’s,DQ’s,RTMs,RiskAssessments,CPPs,VPPs,FATs,SATs,IOQs,NCRs,FinalReports.- Abilitytolift50lbs.- Sciencedegree,orequivalentstudiessuchasMechanical,Electrical,Chemical,Biochemical,Electromechanicalorarelateddisciplinealongwithindustryexperience.- Abilitytohandlemultipleprojectsandworkinafast-pacedenvironment.- Strongmulti-taskingskillsEqualEmploymentOpportunityandReasonableAccommodationsMMRConsultingisanequalopportunityemployer.Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees.Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds.Wearecommittedtoworkingwithandprovidingreasonableaccommodationstoindividualswithdisabilitiesglobally.If,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest.#J-18808-Ljbffr