BIOPHARMACEUTICAL – C&Q Manager

MMR Consulting; Tijuana; Presencial; MXN 1.100.000 - 1.400.000; Jornada completa

Descripción de la vacante

MMR Consulting, an engineering and consulting firm in the pharmaceutical and biotechnology industries, seeks a C&Q Manager to lead validation of bioprocess systems and equipment.

The successful candidate will direct commissioning, qualification, and start-up activities, coordinating with engineers and clients while ensuring GMP compliance and timely project delivery. US client sites may require occasional travel and visa sponsorship considerations.

Formación

• 8+ years in commissioning, qualification or validation in pharma/biotech.
• GMP knowledge including SOPs, Change Controls, Validation.
• Experience with VPP, RTM, IQ/OQ/PQ, FAT/SAT.

Responsabilidades

• Provide technical guidance into commissioning, qualification, and start-up of equipment and facilities used in life science manufacturing.
• Lead the development of qualification deliverables to ensure the project is well defined and tested.
• Leadqualification processes throughout the project lifecycle including VPP, RTM, DQ, FAT, SAT, IQ, OQ, and PQ as appropriate.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of upstream or downstream bioprocess systems is required; exposure to other process equipment is an asset.
• Coordinate meetings with cross-functional departments to drive project progress and decisions.
• Travel occasionally for meetings with clients, vendors, or FATs.
• Support proposals and business development with technical input.

Conocimientos

Leadership

Project management

Team leadership

Multitasking

Fast-paced environment adaptability

Educación

Engineering or science degree

Herramientas

PCS/SCADA

Historian

Siemens Insight

Desigo

Descripción del empleo

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

• ExcellentwrittenandspokenEnglishisrequiredincludingthepreparationoftechnicaldocumentsin English
• 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.