BIOPHARMACEUTICAL – CQV Manager/PM
About The Position
MMR Consulting is seeking a CQV Manager/PM with previous Pharmaceutical/Biotech experience for a role involving the design, commissioning & qualification, start-up, and project management of various processes, systems, and facilities within the pharmaceutical and biotechnology industries. The successful candidate will lead the CQV activities for filling and packaging operations in a sterile/aseptic pharmaceutical manufacturing environment. This role requires leadership skills to manage teams and independently perform or manage resources for filling and packaging operations, including design, installation, start-up, commissioning, qualification, and operational support for analysis, troubleshooting, and process improvements. The position is based at client facilities in Portland, Oregon.
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 the 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
