Previous Pharmaceutical/Biotechexperienceismandatoryforthisrole. MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries. Itsservicesinclude Engineering, Project Management,and Validation. MMRConsultinghasofficesin Canada, USA,and Australia. Thisisanoutstandingopportunitytojoinourgrowingteam,wherethesuccessfulcandidatewillworkwithagroupofengineersinvolvedinthedesign,commissioning,qualification,start-upandprojectmanagementofvariousprocesses,systems,andfacilities. Theidealcandidateshouldpossessleadershipskillstoleadteamsofintermediate,juniorengineers. Thisroleisfor C& 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. Leadqualificationprocessesthroughouttheprojectlifecyclesuchas VPP, Risk Assessments, RTM, DQ, FAT, SAT, IQ, OQand PQasappropriatetoensuretimelycompletionandtoensureallspecificationsaremet. Prepareprotocols,executeprotocols,summarizedata,resolvedeviations,preparefinalreports. Experiencewith C& Qofupstreamordownstreambioprocesssystemsisrequired.



Experiencewith C& Qofotherprocessequipment,utilities,facilitiesisanasset. Thermal Validationexperienceisanasset. Coordinatemeetingswithcross-functionaldepartments,todriveprojectprogress,facilitatedecisions,provideupdates. Engageotherdepartments,asrequired,fordesignreviewsanddecisions. Travelmaybeoccasionallyrequiredformeetingswithclients,equipmentfabricationvendorsor Factory Acceptance Testing(FATs). Workmayrequireoccasionalsupportovershutdownsorextendedhours,specificallyduringinstallationandcommissioning/validationphases. Client-management(maintainkey Clientrelationshipsinsupportofbusinessdevelopmentandpursuitofnewwork),projectscheduling/budgeting,coordinationofclientand MMRresourcesforeffectiveprojectdelivery,supportingbusinessdevelopment(providingtechnicalsupporttothesalesasrequiredforproposals/opportunities),presentingatindustryconferences/publishingpapersetc. Visitconstructionandinstallationsitesfollowingallsitesafetyrequirements. Otherdutiesasassignedbyclient,and/or MMR,basedonworkloadandprojectrequirements. Qualifications Excellentwrittenandspoken Englishisrequiredincludingthepreparationoftechnicaldocumentsin English Yearsofexperience:8+yearsforyearsofexperienceincommissioning,qualificationorvalidationofvarioussystemswithinthepharmaceutical/biotechindustry. Knowledgeofrequirementsforac GMPoperations,including SOPs, Change Controls, Validation.



Experiencewithdevelopingandexecutingvalidationprojects. Risk-Based Commissioning, Qualificationapproaches,suchas ASTME-2500or ISPEICQ,isconsideredanasset,butnotrequired. Experiencewithcommissioningandqualificationofbiotechprocessequipment(upstreamordownstreamorboth),suchassome,butnotall,ofthefollowing:fermentation,bioreactors,downstreampurificationprocesses(chromatography, TFF, UF)isrequired Experiencewithcommissioning&qualificationofprocesscontrolsystems;(i.e. PCS, SCADA, Historians)andbuildingautomationsystems(i.e. Siemens Insight/Desigo, JCIMetasys)areconsideredanasset,butnotrequired. Experiencewith Qualificationor Validationofcleanutilities, ISOcleanrooms,and Thermal Validationisconsideredanasset. Experiencewithpreparationandexecutionof URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports. Abilitytolift50lbs. Sciencedegree,orequivalentstudiessuchas Mechanical, Electrical, Chemical, Biochemical, Electromechanicalorarelateddisciplinealongwithindustryexperience. Abilitytohandlemultipleprojectsandworkinafast-pacedenvironment. Strongmulti-taskingskills Equal Employment Opportunityand Reasonable Accommodations MMRConsultingisanequalopportunityemployer. Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees. Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds. Wearecommittedtoworkingwithandprovidingreasonableaccommodationstoindividualswithdisabilitiesglobally. If,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest. #J-18808-Ljbffr

📌 Biopharmaceutical - c&q manager (Toluca de Lerdo)
🏢 MMR Consulting
📍 Toluca de Lerdo