Pharmaceutical-Commissioning&Qualification(C&Q)ValidationManager

PreviousPharmaceutical/Biotechexperienceismandatoryforthisrole.

MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceutical,andbiotechnologyindustries.ItsservicesincludeEngineering,ProjectManagement,ValidationandotherConsultingservices.MMRhasofficesinCanada,USA,andAustralia.

Thisisanoutstandingopportunitytojoinourgrowingteam,wherethesuccessfulcandidatewillworkwithagroupofengineersandspecialistsinvolvedintheprojectmanagement,commissioningandqualification,ofequipment,systemsandfacilities.ThisroleisbasedoutoftheGreaterToronto,ONarea.Sometravelisexpected.

ThisroleisforaCommissioning&Qualification(C&Q)ValidationManagertoworkonthecommissioning,qualification,startupsystemsinthepharma/biotechindustry.Theidealcandidateshouldpossessleadershipskillstolead/mentorjuniorengineers.

Responsibilities

• Directlymanage/leadateamofCQVengineers/specialists
• Providetechnicalguidanceintothecommissioning,qualificationandstart-upofvariouspharmaceutical/biopharmaceuticalcGMPprocessequipment,utilities&facilities.
• Leadthedevelopment(forexample,writetestcases)ofkeyqualificationdeliverablessuchasDQ,FAT,SAT,IQ,OQandPQduringtheprojectlifecycle
• Abletoperformfieldexecutionofqualificationtestcasesandprotocols
• SupportdevelopmentofProjectValidationPlans(PVPs)toensuretheactionplantotestthesystemisapplicableandrelevant.
• Leadqualificationprocessesthroughouttheprojectlifecycletoensuretimelycompletionandtoensureallqualityandengineeringspecificationsaremet.
• PossessknowledgeofrelevantregulatoryrequirementsandindustrybestpracticesonalloranyofthefollowingProcessequipment,cleanutilities,automationsystems,laboratoryequipment,building&facilities
• Coordinatemeetingswithcross-functionaldepartments,todriveprojectprogress,facilitatedecisions,provideupdates.
• Engageotherdepartments,asrequired,intodesignreviewsanddecisions.
• TravelmaybeoccasionallyrequiredformeetingswithequipmentfabricationvendorsorFactoryAcceptanceTesting(FATs).
• Workmayrequireoccasionalsupportovershutdownsorextendedhours,specificallyduringinstallation,construction,commissioning,qualificationandvalidationphases.
• Visitconstructionandinstallationsites,wearingnecessarysafetyPPE.
• Youmaybeinvolvedwithotheraspectssuchasclient-management(maintainkeyClientrelationshipsinsupportofbusinessdevelopmentandpursuitofnewwork),projectscheduling/budgeting,coordinationofclientandMMRresourcesforeffectiveprojectdelivery,supportingbusinessdevelopment(providingtechnicalsupporttothesalesasrequiredforproposals/opportunities),presentingatindustryconferences/publishingpapersetc.
• Supervisecontractorsduringcriticaltestingofsystemandequipment.
• Otherdutiesasassignedbyclient,and/orMMR,basedonworkloadandprojectrequirements.
• Asthispositionrequiresworkingonclientsites,youwillneedtocomplywiththeclientssafetyrulesincludingmandatoryvaccinationpoliciesforCOVID-19,whereapplicable

Qualifications

• 8+yearsofexperienceincommissioning,qualificationorvalidationofvarioussystemswithinthepharmaceutical/biotechindustry.
• Somepreviousleadershipexperienceisrequired.
• Experiencewithcommissioning&qualificationofequipment&facilitiesisrequired.
• Validationexperiencesuchascleaningvalidation,thermalvalidation,mixingstudies,processvalidation,computersystemsvalidationisanassetbutnotrequired.
• Previousexperienceinthepharmaceutical/biotechindustry,withknowledgeofrequirementsforcGMPoperations.
• ExperiencewithdevelopingandexecutingvalidationprojectstoRisk-BasedCommissioning&Qualificationapproaches,suchasASTME-2500orISPEICQ,isconsideredanasset,butnotrequired.
• Experiencewithcommissioning&qualificationofprocesscontrolsystems(i.e.PCS,SCADA,Historians)andbuildingautomationsystemsareconsideredanasset.
• Experiencewithcommissioningandqualificationofbiotechprocessequipment,suchassome,butnotall,ofthefollowing:fermentation,bioreactors,downstreampurificationprocesses(chromatography,TFF,UF)wouldbeanasset.
• ExperiencewithQualificationorValidationofcleanutilitiesandISOcleanrooms.
• ExperiencewithpreparationandexecutionofURSs,DQs,RTMs,RiskAssessments,CPPs,VPPs,FATs,SATs,IOQs
• LeadteamsofValidationstaff,managestaffpriorities,providementorship/oversight,helpstaffresolveissues.Leadershipisconsideredanasset,butnotrequired.
• Possessleadershipskills,andbeabletotakeinitiativetoleadprojects,involvingmultiplestakeholders,departments,andvaryingcomplexity.
• Possessmentorshipskills,tocoachanddevelopjuniorandintermediateemployees.
• Engineeringdegree,preferablyinMechanical,ElectricalorChemical.
• Travelmayberequiredonoccasion.
• Abilitytohandlemultipleprojectsandworkinafast-pacedenvironment.
• Strongmulti-taskingskills

Compensation: Salary starts from 85k/year + benefits

The base salary offered will be determined by the successful candidates relevant experience, skills, and competencies, while ensuring internal equity is maintained. Experienced candidates may be offered a higher salary range based on their level of expertise and qualifications.

Artificial intelligence (AI) is used during the screening of applications.

EqualEmploymentOpportunityandReasonableAccommodations

MMRConsultingisanequalopportunityemployer.Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees.Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds.Wearecommittedtoworkingwithandprovidingreasonableaccommodationstoindividualswithdisabilitiesglobally.If,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest.