PHARMACEUTICAL – JR. CQV ENGINEER

MMR Consulting; Boulder (CO); On-site; USD 80,000 - 115,000; Full time

Job summary

MMR Consulting in Colorado is seeking a Jr. CQV Engineer to join a growing team. You will work with engineers on the design, commissioning, qualification, start-up and project management of biopharma processes, equipment and facilities.

The ideal candidate has 2–4 years of experience in commissioning/qualification/validation, familiarity with cGMP, and the ability to lead junior engineers. Travel to client sites in the greater Denver/Boulder area may be required.

Qualifications

• 2-4 years of experience in commissioning, qualification or validation in pharma/biotech.
• Knowledge of cGMP operations and regulatory expectations.
• Experience with validation project development and execution is preferred.

Responsibilities

• Provide technical guidance in commissioning, qualification and startup of pharmaceutical/biopharmaceutical equipment and facilities.
• Lead development of qualification deliverables (DQ, FAT, SAT, IQ, OQ, PQ).
• Perform field execution of qualification tests and protocols.
• Support development of Project Validation Plans to test system applicability.
• Lead qualification processes to ensure timely completion and compliance with specs.

Skills

CQV

Leadership

Project management

GMP

Education

Engineering degree

Tools

PCS/SCADA

Job description

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.