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).
ResponsibilitiesProvidetechnicalguidanceintothecommissioning,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.QualificationsExcellentwrittenandspokenEnglishisrequiredincludingthepreparationoftechnicaldocumentsinEnglishYearsofexperience:8+yearsforyearsofexperienceincommissioning,qualificationorvalidationofvarioussystemswithinthepharmaceutical/biotechindustry.KnowledgeofrequirementsforacGMPoperations,includingSOPs,ChangeControls,Validation.Experiencewithdevelopingandexecutingvalidationprojects.Risk-BasedCommissioning,Qualificationapproaches,suchasASTME-****orISPEICQ,isconsideredanasset,butnotrequired.Experiencewithcommissioningandqualificationofbiotechprocessequipment(upstreamordownstreamorboth),suchassome,butnotall,ofthefollowing:fermentation,bioreactors,downstreampurificationprocesses(chromatography,TFF,UF)isrequiredExperiencewithcommissioning&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-*****-Ljbffr

📌 Biopharmaceutical – C&Q Manager (Estado de México)
🏢 MMR Consulting
📍 Estado de México