PHARMACEUTICAL – JR. CQV ENGINEER

MMR Consulting; San Francisco (CA); On-site; USD 80,000 - 115,000; Full time

Job summary

MMRConsulting invites applications for a Jr. CQV Engineer to join our biopharma/biotech project teams.

You will work on the validation of upstream and downstream bioprocess systems and equipment, and support processing equipment validation across cGMP projects. You will lead development and execution of qualification deliverables (DQ, FAT, SAT, IQ, OQ, PQ), perform field execution, and coordinate cross-functional reviews with customers and contractors.

Qualifications

• 2-4 years of experience in commissioning, qualification or validation in pharma/biotech.
• Previous pharma/biotech experience with knowledge of cGMP operations.
• Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset.

Responsibilities

• Provide technical guidance in commissioning, qualification and start-up of pharmaceutical/biopharmaceutical equipment, utilities and facilities.
• Lead development of qualification deliverables (DQ, FAT, SAT, IQ, OQ, PQ) during the project lifecycle.
• Able to perform field execution of qualification test cases and protocols.
• Coordinate project validation plans to ensure tests are applicable and relevant.
• Lead qualification processes to ensure timely completion and quality specifications are met.
• Travel occasionally for meetings with vendors or FATs.
• Visit construction and installation sites and comply with safety rules.

Skills

Commissioning

Qualification

Validation

cGMP

Project management

Leadership

Education

Engineering degree

Tools

PCS

SCADA

Historians

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.