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 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.

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

ExcellentwrittenandspokenEnglishisrequiredincludingthepreparationoftechnicaldocumentsinEnglish

Yearsofexperience:8+yearsforyearsofexperienceincommissioning,qualificationorvalidationofvarioussystemswithinthepharmaceutical/biotechindustry.





KnowledgeofrequirementsforacGMPoperations,includingSOPs,ChangeControls,Validation.

Experiencewithdevelopingandexecutingvalidationprojects.Risk-BasedCommissioning,Qualificationapproaches,suchasASTME-2500orISPEICQ,isconsideredanasset,butnotrequired.

Experiencewithcommissioningandqualificationofbiotechprocessequipment(upstreamordownstreamorboth),suchassome,butnotall,ofthefollowing:fermentation,bioreactors,downstreampurificationprocesses(chromatography,TFF,UF)isrequired

Experiencewithcommissioning&qualificationofprocesscontrolsystems;(i.e.PCS,SCADA,Historians)andbuildingautomationsystems(i.e.SiemensInsight/Desigo,JCIMetasys)areconsideredanasset,butnotrequired.

ExperiencewithQualificationorValidationofcleanutilities,ISOcleanrooms,andThermalValidationisconsideredanasset.

ExperiencewithpreparationandexecutionofURS’s,DQ’s,RTMs,RiskAssessments,CPPs,VPPs,FATs,SATs,IOQs,NCRs,FinalReports.

Abilitytolift50lbs.

Sciencedegree,orequivalentstudiessuchasMechanical,Electrical,Chemical,Biochemical,Electromechanicalorarelateddisciplinealongwithindustryexperience.

Abilitytohandlemultipleprojectsandworkinafast-pacedenvironment.

Strongmulti-taskingskills

EqualEmploymentOpportunityandReasonableAccommodations

MMRConsultingisanequalopportunityemployer.Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees.Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds.Wearecommittedtoworkingwithandprovidingreasonableaccommodationstoindividualswithdisabilitiesglobally.If,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest.

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