Pharmaceutical – Jr. Cqv Engineer

MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries.

Itsservicesinclude Engineering,Project Management,and Validation.

MMRConsultinghasofficesin

Canada,USA,and Australia.

Thisisanoutstandingopportunitytojoinourgrowingteam,wherethesuccessfulcandidatewillworkwithagroupofengineersinvolvedinthedesign,commissioning&qualification,start-upandprojectmanagementofvariousprocesses,systems,and facilities.

Thisroleisfor Jr.CQVEngineerwillrequiretoworkonthevalidationofupstreamanddownstreambioprocesssystems/equipmentinthebiopharmaceuticalindustry,aswellasprocessequipmentinpharma/biotech industries.

Theidealcandidateshouldpossessleadershipskillstoleadteamsofintermediate&junior engineers.

Theworkwillrequireworkingoutofclient’sfacilities,whicharetypicallyinthe

Greater

Denver/Boulder Colorado&surrounding areas.

• Providetechnicalguidanceinthecommissioning,qualificationandstart-upofvariouspharmaceutical/biopharmaceuticalcGMPprocessequipment,utilities&facilities.
• Leadthedevelopment(for example,writetestcases) ofkeyqualificationdeliverablessuchasDQ,FAT,SAT,IQ,OQandPQduringtheprojectlifecycle.
• Abletoperformfieldexecutionofqualificationtestcasesandprotocols.
• Supportdevelopmentof Project Validation Plans (PVPs) toensuretheactionplantotestthesystemisapplicableandrelevant.
• Leadqualificationprocessesthroughouttheprojectlifecycletoensuretimelycompletionandtoensureallqualityandengineeringspecificationsaremet.
• Possessknowledgeofrelevantregulatoryrequirementsandindustrybestpracticesonalloranyofthefollowing–Process equipment,clean utilities,automation systems,laboratory equipment,building&facilities
• Coordinatemeetingswithcross-functional departments,todriveprojectprogress,facilitate decisions,andprovideupdates.
• Engageotherdepartments,as required,inthedesignreviewsanddecisions.
• Travelmaybeoccasionallyrequiredformeetingswithequipmentfabricationvendorsor Factory Acceptance Testing (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,where applicable

• 2-4yearsofexperienceincommissioning,qualificationorvalidationofvarioussystemswithinthepharmaceutical/biotech industry.
• Previousexperienceinthepharmaceutical/biotech industry,withknowledgeofrequirementsforcGMPoperations.
• Validationexperiencesuchascleaningvalidation,thermal validation,mixing studies,process validation,computersystemsvalidationisanassetbutnotrequired.
• Experiencewithdevelopingandexecutingvalidationprojectsto Risk-Based Commissioning&Qualification approaches,suchasASTME-2500orISPEICQ,isconsideredanasset,butnotrequired.
• Experiencewithcommissioning&qualificationofprocesscontrolsystems(i.e.PCS,SCADA,Historians) andbuildingautomationsystemsareconsideredanasset.
• Experiencewithcommissioningandqualificationsofbiotechprocessequipment,suchassome,butnotall,ofthefollowing:fermentation,bioreactors,downstreampurificationprocesses(chromatography,TFF,UF),CIPsystems,Buffer systems,Clean Utilitieswouldbeanasset.
• Experience with…