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About the Role
This role involves leading CQV activities for filling and packaging operations within a sterile/aseptic pharmaceutical manufacturing environment. The candidate will work with a team on the design, commissioning, qualification, start-up, and project management of various processes, systems, and facilities, requiring leadership skills to manage teams and activities related to filling and packaging operations.
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.
Requirements
- Previous Pharmaceutical/Biotech experience is mandatory.
- 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.
Skills
- Leadership skills
- Technical skills
- Project Management
- Validation
- CQV (Commissioning, Qualification, Validation)
- Filling and packaging operations
- Sterile / aseptic manufacturing
- cGMP operations
- User Requirements Specifications (URS)
- Design Specifications (DS)
- Functional Specifications (FS)
- Troubleshooting
- Process improvements
- Packaging technologies
- Reliability studies
- Optimization studies
- FAT / SAT / Commissioning / Qualification
Location
- Portland, Oregon
Work Type
- Onsite
- Full-time
Experience Level
- 8+ years
Education Level
- College / Bachelors’ Degree or Diploma in Engineering discipline, preferable Mechanical
Benefits
- Relocation packages
- Travel packages
About the Company
- 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.
Equal Opportunity
- 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.