Previous pharmaceutical or biotechnology experience is mandatory.
A college degree, bachelor’s degree, or diploma in an engineering discipline is required; Mechanical Engineering is preferred.
At least 8 years of experience in a GxP environment, typically designing or operating pharmaceutical packaging operations, including sterile or aseptic manufacturing.
Knowledge of cGMP operational requirements and experience in the pharmaceutical or biotechnology industry.
Ability to take initiative and lead projects involving multiple stakeholders, departments, and varying complexity.
Ability to handle multiple projects in a fast-paced environment.
Ability to lift 50 pounds.
Occasional travel or off-hours work may be required.
Responsibilities
Lead or participate in designing or operating the packaging of pharmaceutical products into final forms and containers through fill/finish and packaging, including vials, syringes, and other delivery systems.
Lead or support project execution from feasibility through project completion and handover.
Develop and manage commissioning, qualification, and validation (CQV) strategies, project plans, schedules, budgets, and resource allocation.
Communicate with senior leadership and site-level teams.
Work with production and packaging groups to create User Requirements Specifications (URS) for ongoing operations or new projects.
Collaborate with vendors for packaging machinery, equipment systems, automation controls, materials, and consumables to create Design Specifications (DS) and Functional Specifications (FS) for solutions that reduce contamination risks and process failures.
Assess current packaging operations for troubleshooting, efficiency, and continuous-improvement opportunities.
Lead innovations in packaging technologies to support existing client needs.
Perform reliability studies on packaging equipment.
Perform optimization studies to determine optimal use of packaging equipment systems in campaigns.
Support documentation and/or execution of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and qualification of packaging systems.
Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates to higher management.
Provide other duties as assigned by the client or MMR, based on workload and project requirements.
Provide occasional support during shutdowns or extended hours, particularly during installation and commissioning/validation phases.
Previous Pharmaceutical/Biotech experience is mandatory for this role.
Relocation packages or travel packages are available for this role.
The work will require working out of client’s facilities, in Portland, Oregon.
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.
MMR Consulting has offices in Canada, USA, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
This role is to Lead the CQV activities for the filling and packaging operations 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.
The work will require working out of client’s facilities, which are in Portland, Oregon.
Responsibilities
Lead or participate in design or operations of packaging pharmaceutical products into their final forms and containers by fill / finish and packaging like, vials, syringes and other delivery systems.
Lead or support project execution from feasibility through to project completion/handover.
Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.
Communicate effectively with senior leadership and site-level teams.
Work with production and packaging groups to create User Requirements Specifications (URS) for ongoing operations or new projects
Collaborate with vendors for packaging machinery, equipment systems, automation controls, materials and consumables, to create Design Specifications (DS) and Functional Specifications (FS) to implement solutions for reducing contamination risks & process failures
Assess current packaging operations for troubleshooting, efficiencies and continuous improvement opportunities
Spearhead innovations in packaging technologies to support existing client needs
Perform reliability studies on packaging equipment
Perform optimization studies for the optimal use of packaging equipment systems for use in campaigns
Support documentation and/or execution of FAT / SAT / Commissioning, Qualification of packaging systems
Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, provide updates to higher management
Other duties as assigned by client, and / or MMR, based on workload and project requirements.
Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases
Qualifications
College / Bachelors’ Degree or Diploma in Engineering discipline, preferable Mechanical
8+ years in GxP environment typically for design or operation of pharmaceutical packaging operations, including sterile / aseptic manufacturing
Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for a cGMP operations
Possess leadership skills and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity
Ability to handle multiple projects and work in a fast-paced environment.
Ability to lift 50 pounds
Travel and / or off-hours work may be required on occasion
As part of our recruitment process, we may use technology-assisted tools, including AI-enabled systems, to support application review and candidate evaluation. Hiring decisions are made with human oversight and consideration.
Equal Employment Opportunity and Reasonable Accommodations
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.