MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries.ItsservicesincludeEngineering,ProjectManagement,andValidation.
MMRConsultinghasofficesinCanada,USA,andAustralia.
Thisisanoutstandingopportunitytojoinourgrowingteam,wherethesuccessfulcandidatewillworkwithagroupofengineersinvolvedinthedesign,commissioning&qualification,start-upandprojectmanagementofvariousprocesses,systems,andfacilities.
ThisroleisforJr.CQVEngineerwillrequiretoworkonthevalidationofupstreamanddownstreambioprocesssystems/equipmentinthebiopharmaceuticalindustry,aswellasprocessequipmentinpharma/biotechindustries.Theidealcandidateshouldpossessleadershipskillstoleadteamsofintermediate&juniorengineers.
Theworkwillrequireworkingoutofclient’sfacilities,whicharetypicallyintheGreaterDenver/BoulderColorado&surroundingareas.
Responsibilities
- Providetechnicalguidanceinthecommissioning,qualificationandstart-upofvariouspharmaceutical/biopharmaceuticalcGMPprocessequipment,utilities&facilities.
- Leadthedevelopment(forexample,writetestcases)ofkeyqualificationdeliverablessuchasDQ,FAT,SAT,IQ,OQandPQduringtheprojectlifecycle.
- Abletoperformfieldexecutionofqualificationtestcasesandprotocols.
- SupportdevelopmentofProjectValidationPlans(PVPs)toensuretheactionplantotestthesystemisapplicableandrelevant.
- Leadqualificationprocessesthroughouttheprojectlifecycletoensuretimelycompletionandtoensureallqualityandengineeringspecificationsaremet.
- Possessknowledgeofrelevantregulatoryrequirementsandindustrybestpracticesonalloranyofthefollowing–Processequipment,cleanutilities,automationsystems,laboratoryequipment,building&facilities
- Coordinatemeetingswithcross-functionaldepartments,todriveprojectprogress,facilitatedecisions,andprovideupdates.
- Engageotherdepartments,asrequired,inthedesignreviewsanddecisions.
- TravelmaybeoccasionallyrequiredformeetingswithequipmentfabricationvendorsorFactoryAcceptanceTesting(FATs).
- Workmayrequireoccasionalsupportovershutdownsorextendedhours,specificallyduringinstallation,construction,commissioning,qualification,andvalidationphases.
- Visitconstructionandinstallationsites,wearingnecessarysafetyPPE.
- Youmaybeinvolvedwithotheraspectssuchasclient-management(maintainkeyClientrelationshipsinsupportofbusinessdevelopmentandpursuitofnewwork),projectscheduling/budgeting,coordinationofclientandMMRresourcesforeffectiveprojectdelivery,supportingbusinessdevelopment(providingtechnicalsupporttothesalesasrequiredforproposals/opportunities),presentingatindustryconferences/publishingpapersetc.
- Supervisecontractorsduringcriticaltestingofsystemandequipment.
- Otherdutiesasassignedbyclient,and/orMMR,basedonworkloadandprojectrequirements.
- Asthispositionrequiresworkingonclientsites,youwillneedtocomplywiththeclient’ssafetyrulesincludingmandatoryvaccinationpoliciesforCOVID-19,whereapplicable
Qualifications
- 2-4yearsofexperienceincommissioning,qualificationorvalidationofvarioussystemswithinthepharmaceutical/biotechindustry.
- Previousexperienceinthepharmaceutical/biotechindustry,withknowledgeofrequirementsforcGMPoperations.
- Validationexperiencesuchascleaningvalidation,thermalvalidation,mixingstudies,processvalidation,computersystemsvalidationisanassetbutnotrequired.
- ExperiencewithdevelopingandexecutingvalidationprojectstoRisk-BasedCommissioning&Qualificationapproaches,suchasASTME-2500orISPEICQ,isconsideredanasset,butnotrequired.
- Experiencewithcommissioning&qualificationofprocesscontrolsystems(i.e.PCS,SCADA,Historians)andbuildingautomationsystemsareconsideredanasset.
- Experiencewithcommissioningandqualificationsofbiotechprocessequipment,suchassome,butnotall,ofthefollowing:fermentation,bioreactors,downstreampurificationprocesses(chromatography,TFF,UF),CIPsystems,Buffersystems,CleanUtilitieswouldbeanasset.
- ExperiencewithQualificationorValidationofcleanutilitiesandISOcleanrooms.
- ExperiencewithpreparationandexecutionofURS’s,DQ’s,RTMs,RiskAssessments,CPPs,VPPs,FATs,SATs,IOQs
- Engineeringdegree,preferablyinMechanical,ElectricalorChemical.
- Travelmayberequiredonoccasion.
- Abilitytohandlemultipleprojectsandworkinafast-pacedenvironment.
- Strongmulti-taskingskills
- Abilitytolift50lbs.
Compensation:80,000$-115,000$basedonexperience.
Aspartofourrecruitmentprocess,wemayusetechnology-assistedtools,includingAI-enabledsystems,tosupportapplicationreviewandcandidateevaluation.Hiringdecisionsaremadewithhumanoversightandconsideration.
EqualEmploymentOpportunityandReasonableAccommodations
MMRConsultingisanequalopportunityemployer.Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees.Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds.Wearecommittedtoworkingwithandprovidingreasonableaccommodationstoindividualswithdisabilitiesglobally.If,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest.
