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-****or 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.
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📌 Biopharmaceutical – C&Q Manager (Tijuana)
🏢 MMR Consulting
📍 Tijuana