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 clients 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
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 clients 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.ExperiencewithpreparationandexecutionofURSs,DQs,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...
Previous Pharmaceutical/Biotech experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation. MMR Consulting has offices in
Research Associate I/II - Biologics Purification & Characterization (Temporary, 1-year contract; on-site in San Rafael, five days per week) Position Summary Support biologics purification and analytical characterization, with a primary focus on enzymes and additional exposure
Research Associate I/II - Biologics Purification & Characterization (Temporary, 1-year contract; on-site in San Rafael, five days per week)Position SummarySupport biologics purification and analytical characterization, with a primary focus on enzymes and additional exposure to other
Previous Pharmaceutical/Biotech experience is mandatory for this roleMMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.MMR Consulting has offices in Canada, USA,
Descripción del puesto Como Asesor/a de Ventas Industriales en TFF de México, serás responsable de la identificación y desarrollo de nuevas oportunidades de negocio en el sector industrial. Tus tareas diarias incluirán asesorar a los clientes sobre