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. bioMérieux’s global headquarters is located in Marcy L’Étoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. Our Americas headquarters is in Durham, NC, with nearly 1,200 team members. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.
The purpose of this position is to to troubleshoot, investigate and resolve issues with the product that arise in manufacturing, Develop, validate and implement changes that would support process improvements, provide chemical/biological support and expertise for the manufacturing engineering department.
- Design, conduct and interpret experiments to determine upper and lower specification limits for manufacturing process steps in order to maintain optimum chemical and microbiological performance.
- Design, set up, execute, and interpret results from experiments to improve the robustness of the current process steps.
- Identify/establish Standard methods of Manufacturing and ensure that developed products follow the identified methods.
- Solve technical problems of moderate to high complexity, lead troubleshooting efforts to determine root causes for failures and customer complaints.
- Design, conduct, and interpret results from experiments to support development of improved formulations and to enhance product quality and performance.
- Involve close collaboration with R&D reagent scientist colleagues to assure the manufacturability prior product transfer to Production.
- Provide scientific expertise and participate on departmental and cross-functional teams focused on the delivery of new or improved products.
- Additional duties include maintaining a laboratory notebook, writing technical reports, internal protocols and SOPs.
- Produces and presents technical reports as needed.
- Lead cross-functional project teams, track and document project results, organizes and assures appropriate dissemination of documentation in accordance with company quality policy and design control procedures.
- Provides technical expertise in the relationship between antimicrobials, growth medium, and pH requirements in regards to microbiological performance.
- Interact with Engineers to provide potential product impacts for new equipment, equipment upgrades and equipment specification changes.
- Temporary modification to provide reasonable accommodations do not waive any essential functions of the job requirements.
Studies/Experience, Skills and Qualifications:
- B.S in Chemistry or Chemical /Biochemical Engineering Required.
- Strong PC skills (Word, Excel, Access, etc.).
- Knowledge of ISO 9001 and Quality System Regulation.
- Working knowledge GMP and GLP requirements.
- Working knowledge of an MES system.
- Working knowledge of utilizing statistical software packages (ex minitab, SigmaStat).
- Database management and creation through access is desired.
- Project management training is desired.
- Six Sigma training desired.
- Root Cause Analysis training preferred.
- Exposure to Lean Manufacturing is preferred.
- Lifting (up to 25 lbs) office products and supplies and moving containers of various materials.
- 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.
Name: Tamela Smith