Previous Pharmaceutical/Biotech experience is mandatory for this role.
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.
