BIOPHARMACEUTICAL – CQV Manager/PM
About The Position
MMR Consulting is seeking a CQV Manager/PM with previous Pharmaceutical/Biotech experience for a role in Portland, Oregon. This position involves leading Commissioning, Qualification, and Validation (CQV) activities for filling and packaging operations within a sterile/aseptic pharmaceutical manufacturing environment. The role requires a blend of technical expertise and leadership skills to manage teams and oversee projects from design through to completion. The candidate will work with engineers on various processes, systems, and facilities, focusing on filling and packaging equipment systems, including analysis, troubleshooting, and process improvements.
Requirements
- Previous Pharmaceutical/Biotech experience is mandatory.
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
