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. ,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-taskingskills EqualEmploymentOpportunityandReasonableAccommodations ,qualifications,,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest. #J-18808-Ljbffr