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.

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