Previous Pharmaceutical/Biotechexperienceismandatoryforthisrole.
MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries. Itsservicesinclude Engineering, Project Management,and Validation.
MMRConsultinghasofficesin Canada, USA,and Australia.

Thisisanoutstandingopportunitytojoinourgrowingteam,wherethesuccessfulcandidatewillworkwithagroupofengineersinvolvedinthedesign,commissioning&qualification;,start-upandprojectmanagementofvariousprocesse 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(chromatogr 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 (Tijuana)
🏢 MMR Consulting
📍 Tijuana