This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
Job description
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.
#J-18808-Ljbffr
Worksite address
portland, OR, 97204, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.