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
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
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 nuestros
Desde mAbbxience, compañía especializada en el desarrollo y fabricación de medicamentos biosimilares incorporamos un/a analista DSP temporal para nuestra planta en León. Usted podría ser el solicitante perfecto para este trabajo. Lea toda la información asociada
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
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. ,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-taskingskillsEqualEmploymentOpportunityandReasonableAccommodations,qualifications,,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest. #J- *-Ljbffr...
