BIOPHARMACEUTICAL - CQV Manager/PM

PreviousPharmaceutical/Biotechexperienceismandatoryforthisrole.

MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries.ItsservicesincludeEngineering,ProjectManagement,andValidation.

MMRConsultinghasofficesinCanada,USA,andAustralia.

Thisisanoutstandingopportunitytojoinourgrowingteam,wherethesuccessfulcandidatewillworkwithagroupofengineersinvolvedinthedesign,commissioning&qualification,start-upandprojectmanagementofvariousprocesses,systems,andfacilities.Theidealcandidateshouldpossessleadershipskillstoleadteamsofintermediate&juniorengineers.

ThisroleistoLeadtheCQVactivitiesforthefillingandpackagingoperationswithinasterile/asepticpharmaceuticalmanufacturingenvironment.Tasksmayincludeallorinpart,design/re-design,installation,start-up/commissioning,qualificationaswellasoperationsupportforanalysis,troubleshootingand/orprocessimprovementsofthefilling/packagingequipmentsystems.Theidealcandidateshouldpossesstechnicalaswellasleadershipskillstoindependentlyperformormanageresourcesandactivitiesrelatedtothefillingandpackagingoperations.

Theworkwillrequireworkingoutofclient’sfacilities,whichareinPortland,Oregon.

Responsibilities

• Leadorparticipateindesignoroperationsofpackagingpharmaceuticalproductsintotheirfinalformsandcontainersbyfill/finishandpackaginglike,vials,syringesandotherdeliverysystems.
• Leadorsupportprojectexecutionfromfeasibilitythroughtoprojectcompletion/handover.
• DevelopandmanageCQVstrategies,projectplans,schedules,budgets,andresourceallocation.
• Communicateeffectivelywithseniorleadershipandsite-levelteams.
• WorkwithproductionandpackaginggroupstocreateUserRequirementsSpecifications(URS)forongoingoperationsornewprojects
• Collaboratewithvendorsforpackagingmachinery,equipmentsystems,automationcontrols,materialsandconsumables,tocreateDesignSpecifications(DS)andFunctionalSpecifications(FS)toimplementsolutionsforreducingcontaminationrisks&processfailures
• Assesscurrentpackagingoperationsfortroubleshooting,efficienciesandcontinuousimprovementopportunities
• Spearheadinnovationsinpackagingtechnologiestosupportexistingclientneeds
• Performreliabilitystudiesonpackagingequipment
• Performoptimizationstudiesfortheoptimaluseofpackagingequipmentsystemsforuseincampaigns
• Supportdocumentationand/orexecutionofFAT/SAT/Commissioning,Qualificationofpackagingsystems
• Coordinatemeetingswithcross-functionaldepartmentstodriveprojectprogress,facilitatedecisions,provideupdatestohighermanagement
• Otherdutiesasassignedbyclient,and/orMMR,basedonworkloadandprojectrequirements.
• Workmayrequireoccasionalsupportovershutdownsorextendedhours,specificallyduringinstallationandcommissioning/validationphases

Qualifications

• College/Bachelors’DegreeorDiplomainEngineeringdiscipline,preferableMechanical
• 8+yearsinGxPenvironmenttypicallyfordesignoroperationofpharmaceuticalpackagingoperations,includingsterile/asepticmanufacturing
• Previousexperienceinthepharmaceutical/biotechindustry,withknowledgeofrequirementsforacGMPoperations
• Possessleadershipskillsandbeabletotakeinitiativetoleadprojects,involvingmultiplestakeholders,departments,andvaryingcomplexity
• Abilitytohandlemultipleprojectsandworkinafast-pacedenvironment.
• Abilitytolift50pounds
• Traveland/oroff-hoursworkmayberequiredonoccasion

Aspartofourrecruitmentprocess,wemayusetechnology-assistedtools,includingAI-enabledsystems,tosupportapplicationreviewandcandidateevaluation.Hiringdecisionsaremadewithhumanoversightandconsideration.

EqualEmploymentOpportunityandReasonableAccommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.