Biopharmaceutical - Senior CQV Engineer in Seattle

Job Description Job Description

Previous Pharmaceutical/Biotech experienceismandatoryforthisrole.

Relocation packages or travel packages are available for this role.

The work will require working out of client’s facilities, in Portland, Oregon.

MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries.

Itsservicesinclude Engineering,Project Management,and Validation.

MMRConsultinghasofficesin

Canada,USA,and Australia.

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

Theidealcandidateshouldpossessleadershipskillstoleadteamsofintermediate&junior engineers.

This role is for to work on the CQV activities for filling and packaging facility within a sterile / aseptic pharmaceutical manufacturing environment. Tasks may include all or in part, design / re-design, installation, start-up / commissioning, qualification as well as operation support for analysis, trouble shooting and / or process improvements of the filling / packaging equipment systems. The ideal candidate should possess technical as well as leadership skills to independently perform or manage resources and activities related to the filling and packaging operations.

Theworkwillrequireworkingoutofclient’sfacilities,whichare
in 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-assistedtools,including AI-enabledsystems,tosupportapplicationreviewandcandidateevaluation.

Hiringdecisionsaremadewithhumanoversightandconsideration.

MMR Consulting is an equal opportunity employer. We celebrate 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 , you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.