BIOPHARMACEUTICAL – CQV Manager/PM

MMR Consulting; Portland (OR); On-site; USD 120,000 - 170,000; Full time

Job summary

MMR Consulting in the United States Portland area seeks a senior engineer to lead CQV activities for filling and packaging operations in a sterile/aseptic pharmaceutical manufacturing environment. You will design, start-up, qualify, and support operations, guiding teams of intermediate and junior engineers through project execution.

The role requires leadership, collaboration with production and packaging groups, and the ability to manage multiple projects, budgets, and schedules while ensuring

Qualifications

• Bachelor's degree in Engineering (Mechanical preferred).
• 8+ years in GMP packaging design/operation for sterile/aseptic pharma.
• Previous pharmaceutical/biotech experience with GMP requirements.
• Proven leadership to lead multi-stakeholder projects.

Responsibilities

• Lead or support CQV design and operation of packaging lines.
• Develop CQV strategies, plans, schedules, budgets.
• Coordinate with cross-functional teams to drive progress.
• Create URS, DS, FS with vendors for packaging systems.
• Perform troubleshooting and continuous improvement of packaging.
• Occasional travel and shifts during installation/validation.

Skills

Leadership

CQV experience

Project management

GxP knowledge

Sterile packaging

Education

Bachelor's degree in Engineering

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.