A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.
Provide support for equipment related projects within the Reagent Operations Engineering Department. This includes leading and documenting projects from start to finish.
- Oversees and assesses existing manufacturing processes and workflows.
- Optimizes productivity by designing, implementing and testing new procedures in manufacturing.
- Assembles reports to document process status and changes.
- Tracks metrics in manufacturing to discover areas for improvement and monitor upgrades.
- Communicates findings and proposals to upper management.
- Utilizes process simulation software to test and find the most appropriate production strategies.
- Provides thorough instructions for successful implementation of process changes.
- Conducts risk assessments.
- Assesses compliance with applicable safety and quality standards.
- Lead and manage raw material related projects
- Develop and execute change controls and other compliance related documentation for raw materials including qualification protocols.
- Collaborate with Reagents Operations Engineering, Manufacturing, Purchasing, and Quality to lead projects and ensure the optimum manufacturing process in terms of keeping manufacturing moving.
- Organize and lead meetings as required to support project timelines.
- Participate in the development of long-term strategies for Raw Materail and process improvements.
- Conduct feasibility studies to assess new technologies or process improvements.
- Support root cause analysis and fishbone activities related to the manufacturing processes.
- Provide timely and accurate reporting on projects.
- Ensure all activities comply with Good Manufacturing Practice (GMP), ISO, and Quality System requirements.
- Ensure that all health, safety, and environmental requirements are fulfilled.
- Support the development of capital business cases for new equipment projects.
- Support any project or task that requires keeping manufacturing running, supplied with raw materials, and ensure quality product is being shipped to customers. This can include performing NC investigation writing and disposition.
Studies, Experience, Skills and Qualifications:
- Bachelor's Degree in Process, Manufacturing, Materials, Mechanical or Industrial Engineering required
- Requires 6+ years of work experience in a manufacturing environment.
- Requires 6+ years of work experience in an FDA regulated environment such as medical devices of pharma.
- Proven experience in conceptualizing process improvements to existing equipment.
- Ability to collaborate professionally with all levels of management in a cross-functional team environment is required.
- Knowledge of FDA/ISO regulations and process validation is preferred.
- Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
- Must have strong communication and interpersonal skills.
- Must have strong analytical and problem-solving skills.
- Extensive standing, repetitive hand and arm motions, ability to climb steps.
- Lifting (up to 50Lbs) and moving containers of cartons, tubes, and printed materials.
- Must be able to push a wheeled cage that can weigh up to 600 lbs fully loaded.
- Operating within cool temperature and low humidity conditions within the production room. Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment.
- Excellent personal hygiene required. Appropriate gowning requirements necessary for the production areas. Gloves are required to handle the product. Hairnet, clean room gowns and/or lab coats are required. Safety glasses and hearing protection are required personal protective gear.
- Occasional environmental odors may be prevalent.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.