PHARMACEUTICAL - JR. CQV ENGINEER
$80k - $115kMMR Consulting
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. #J-18808-Ljbffr MMR Consulting
$85k - $100k
...Role We are hiring experienced validation engineers responsible for the commissioning,... ...facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play... ...and assess risks associated with CQV activities and develop effective mitigation...PharmaceuticalInternshipLocal area$85k - $100k
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Pasadena, CA2 days ago$100k - $115k
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Los Angeles, CAa month ago$56.68 per hour
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Katalyst Healthcares and Life Sciences
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