BIOPHARMACEUTICAL C&Q Manager
$90k - $145kMMR Consulting
Job Description
Job Description
Salary:
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.
Theworkwillrequireworkingoutofclientsfacilities,whichareinBoulder,Colorado.
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.
- ExperiencewithpreparationandexecutionofURSs,DQs,RTMs,RiskAssessments,CPPs,VPPs,FATs,SATs,IOQs,NCRs,FinalReports.
- Abilitytolift50lbs.
- Sciencedegree,orequivalentstudiessuchasMechanical,Electrical,Chemical,Biochemical,Electromechanicalorarelateddisciplinealongwithindustryexperience.
- Abilitytohandlemultipleprojectsandworkinafast -pacedenvironment.
- Strongmulti-taskingskills
Compensation:90,000$-145,000$basedonexperience.
EqualEmploymentOpportunityandReasonableAccommodations
MMRConsultingisanequalopportunityemployer.Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees.Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds.Wearecommittedtoworkingwithandprovidingreasonableaccommodationstoindividualswithdisabilitiesglobally.If,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest.
$90k - $145k
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