BIOPHARMACEUTICAL C&Q Manager

$90k - $145k

MMR Consulting

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.

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Vacancy posted 17 days ago

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