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 System Validation Manager!
We are seeking a highly motivated, organized individual for the position of System Validation Manager to join the System Validation group. This position requires a college degree in a scientific field and a minimum 2 years of experience managing personnel, working with quality system requirements, and managing multiple projects simultaneously.
The System Validation Manager manages a team of research associates, lab assistants, and interns in the execution of studies and validations to meet department and company goals. This person will interact with various company departments and requires strong written and verbal communication skills. The System Validation Manager tracks minor and major milestones and ensures completion of studies and validations within the schedule constraints agreed on by the technical teams involved.
Education and Experience:
- College degree in a scientific field.
- Minimum 2 years of experience managing personnel, working with quality system requirements, and managing multiple projects simultaneously.
Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BFDX’s Quality System.
- Plans execution of laboratory research, verifications, and validations. Writes internal studies and design documents as necessary.
- Manage assigned research associates, lab assistants, and interns in the execution of studies and validations.
- Complete studies and validations within schedule constraints agreed to by the design and validation teams.
- Analyze results using standard computational software and internal BFDX software.
- Plan and track study and validation progress using relevant applications and software.
- Guide direction and preparation of weekly data presentations for decisions on proposed design and process changes.
- Work may involve development of new processes.
- Maintain broad knowledge of current internal validation process and testing and state-of-the-art principles and theories.
- May advise top management on corporate research and development validation progress.
- Interact with various company departments, including members of the system validation team made up of at least development, management, regulatory, production, project management, and quality personnel.
- Use professional concepts to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways.
- Demonstrate potential for technical proficiency, collaboration with others, and independent thought.
- Ensure that laboratory notebooks and internal studies (and design documents) for assigned projects/experiments are maintained in accordance with BFDX Employment Handbook.
- Maintain good documentation for all validation work, including WID’s, validation original paperwork and electronic documentation for submission to quality web.
- Interact with other external validation bodies as necessary.
- Technical writing
- Data analysis
- Project tracking using computer applications and software
- Organization of large data sets and technical files
- Knowledge of quality system requirements
- Personnel management
- Communication skills (verbal and written)