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).
ResponsibilitiesProvidetechnicalguidanceintothecommissioning,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.QualificationsExcellentwrittenandspoken Englishisrequiredincludingthepreparationoftechnicaldocumentsin EnglishYearsofexperience:8+yearsforyearsofexperienceincommissioning,qualificationorvalidationofvarioussystemswithinthepharmaceutical/biotechindustry.Knowledgeofrequirementsforac GMPoperations,including SOPs, Change Controls,



Validation.Experiencewithdevelopingandexecutingvalidationprojects.
Risk-Based Commissioning, Qualificationapproaches,suchas ASTME-****or ISPEICQ,isconsideredanasset,butnotrequired.Experiencewithcommissioningandqualificationofbiotechprocessequipment(upstreamordownstreamorboth),suchassome,butnotall,ofthefollowing:fermentation,bioreactors,downstreampurificationprocesses(chromatography, TFF, UF)isrequiredExperiencewithcommissioning&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-taskingskillsEqual Employment Opportunityand Reasonable AccommodationsMMRConsultingisanequalopportunityemployer.
Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees.
Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds.
Wearecommittedtoworkingwithandprovidingreasonableaccommodationstoindividualswithdisabilitiesglobally.
If,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest.

📌 Biopharmaceutical – C&Q Manager (Toluca de Lerdo)
🏢 MMR Consulting
📍 Toluca de Lerdo