At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.
Come be a part of our team and our mission as a Reagent Manufacturing Project Manager!
The Reagent Manufacturing Project Manager will work with our manufacturing department and subject matter experts to identify areas of improvement, develop validation strategies, and implement changes into manufacturing. Responsibilities include developing and maintaining project timelines, creating project and change control documentation, as well as coordinating and performing qualification and validation activities.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Leads and monitors projects throughout development, initiation, planning, execution, control and closing.
- Acts as the point of contact and expert for assigned projects.
- Develop risk assessment, specifications, validation plans, protocols and reports that support the qualification and validation of manufacturing processes.
- Develop and maintain accurate timelines for multiple projects.
- Plan and oversee the implementation of new and/or improved manufacturing processes and equipment
- Schedule meetings, create agendas, documents meeting minutes, correspondence, and presentations
- Communicates, prepares and presents reports, summaries and analysis to support the project and status of projects.
- Creates and maintains relevant project documentation throughout the project.
- Applies project management best practices throughout the project lifecycle
- Investigates, creates, and develops new methods and technologies for project advancement.
- Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
- Promote QSR and regulatory compliance into assigned projects.
Training and Education
- Minimum education and/or training requirements for this position (i.e. high school diploma, college degree, and/or certification).
- Minimum of Bachelor’s degree in related scientific or engineering field.
- Minimum time and type experience required for this position.
- Minimum two years in project management is desired.
Knowledge, Skills and Abilities
- Knowledge of validation strategies as they pertain to the medical device manufacturing industry
- Ability to relate with people at all levels within an organization
- Must work well independently as well as in a team environment
- Must be an effective communicator
- Must be able to work on multiple projects simultaneously
- Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).