Biopharmaceutical – Senior Filling​/Finish CQV

Previous Pharmaceutical/Biotechexperienceismandatoryforthisrole.

Relocationpackagesortravelpackagesareavailableforthisrole

MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries.

Itsservicesinclude Engineering,Project Management,and Validation.

MMRConsultinghasofficesin

Canada,USA,and Australia.

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

Theidealcandidateshouldpossessleadershipskillstoleadteamsofintermediate&junior engineers.

Thisroleisfortoworkonthefillingandpackagingoperationswithinasterile/asepticpharmaceuticalmanufacturingenvironment.

Tasksmayincludeallorinpart,design/re-design,installation,start-up/commissioning,qualificationaswellasoperationsupportforanalysis,troubleshooting and/orprocessimprovementsofthefilling/packagingequipmentsystems.

Theidealcandidateshouldpossesstechnicalaswellasleadershipskillstoindependentlyperformormanageresourcesandactivitiesrelatedtothefillingandpackagingoperations.

Theworkwillrequireworkingoutofclient’sfacilities,whicharein

Portland,Oregon.

• Leadorparticipateindesignoroperationsofpackagingpharmaceuticalproductsintotheirfinalformsandcontainersbyfill/finishandpackaginglike,vials,syringesandotherdeliverysystems.
• Workwithproductionandpackaginggroupstocreate User Requirements Specifications (URS) forongoingoperationsornewprojects
• Collaboratewithvendorsforpackagingmachinery,equipment systems,automation controls,materialsandconsumables,tocreate
  
  Design
  
  Specifications(DS) and Functional
  
  Specifications(FS) toimplementsolutionsforreducingcontaminationrisks&process failures
• Assesscurrentpackagingoperationsfortroubleshooting,efficienciesandcontinuousimprovementopportunities
• Spearheadinnovationsinpackagingtechnologiestosupportexistingclientneeds
• Performreliabilitystudiesonpackagingequipment
• Performoptimizationstudiesfortheoptimaluseofpackagingequipmentsystemsforuseincampaigns
• Supportdocumentationand/orexecutionofFAT/SAT/Commissioning,Qualificationofpackagingsystems
• Coordinatemeetingswithcross-functionaldepartmentstodriveprojectprogress,facilitate decisions,provideupdatestohighermanagement
• Otherdutiesasassignedbyclient,and/orMMR,basedonworkloadandprojectrequirements.
• Workmayrequireoccasionalsupportovershutdownsorextendedhours,specificallyduringinstallationandcommissioning/validation phases

• College/Bachelors’Degreeor Diplomain Engineering discipline ,preferable Mechanical
• 8+yearsin
  
  GxPenvironmenttypicallyfordesignoroperationofpharmaceuticalpackagingoperations,including sterile/aseptic manufacturing
• Previousexperienceinthepharmaceutical/biotech industry,withknowledgeofrequirementsforacGMPoperations
• Possessleadershipskillsandbeabletotakeinitiativetoleadprojects,involvingmultiplestakeholders,departments,andvaryingcomplexity
• Abilitytohandlemultipleprojectsandworkinafast-paced environment.
• Abilitytolift
  50pounds
• Traveland/oroff-hoursworkmayberequiredonoccasion

Apartofourrecruitmentprocess,wemayusetechnology-assisted tools,including AI-enabled systems,tosupportapplicationreviewandcandidateevaluation.

Hiringdecisionsaremadewithhumanoversightandconsideration.

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.