BIOPHARMACEUTICAL - Senior CQV Engineer in Seattle

Energy Jobline ZR; Seattle (WA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Relocation packages

Travel packages

Job summary

MMR Consulting is seeking an experienced engineer to join our CQV team focused on filling and packaging operations in a sterile/aseptic pharmaceutical environment. The role involves design, commissioning, qualification, and support for packaging systems, with leadership responsibility for junior engineers.

The ideal candidate has a mechanical or engineering degree, 8+ years in GMP environments, pharma/biotech background, and proven ability to lead multidisciplinary projects.

Qualifications

• College/Bachelors’ Degree or Diploma in Engineering, preferably Mechanical.
• 8+ years in GMP environment, for design or operation of packaging operations.
• Previous experience in pharma/biotech with GMP knowledge.
• Leadership to drive projects with multiple stakeholders.
• Ability to handle multiple projects in a fast-paced setting.
• Ability to lift 50 pounds.

Responsibilities

• Lead or participate in design or operation of packaging products and final forms.
• Develop URS for ongoing operations or new projects with cross-functional teams.
• Collaborate with vendors to create DS/FS for packaging solutions.
• Identify opportunities for troubleshooting, efficiencies, and improvements.
• Support FAT/SAT and commissioning, qualification of packaging systems.
• Coordinate meetings across departments to drive progress.

Skills

Pharma/biotech experience

Leadership

GxP environment

Project coordination

Ability to lift 50 lbs

Travel readiness

Education

Bachelor's degree in Engineering

Diploma in Engineering

Job description

Job DescriptionJob 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.ItsservicesincludeEngineering,ProjectManagement,andValidation.

MMRConsultinghasofficesinCanada,USA,andAustralia.

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

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,whichareinPortland,Oregon.

Responsibilities

• Leadorparticipateindesignoroperationsofpackagingpharmaceuticalproductsintotheirfinalformsandcontainersbyfill/finishandpackaginglike,vials,syringesandotherdeliverysystems.
• 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

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

EqualEmploymentOpportunityandReasonableAccommodations

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.