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.

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📌 Biopharmaceutical – C&q Manager (Tijuana)
🏢 MMR Consulting
📍 Tijuana