World leader in the field of in vitro diagnostics for over 50 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.
bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France.
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.
We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.
We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.
Our Group offers numerous possibilities: so come and join the 10,000 bioMérieux employees who have already identified with these values!
Week Day: M-F 8am to 430pm
M ain A cc o un t abiliti e s :
Assist in maintaining an efficient and effective workforce. Maximize equipment and process capabilities. Maintaining the VITEK 2 rework operation so that it is GMP compliant and meets FDA and ISO requirements. Maximize productivity with a goal of operating the rework equipment to meet and exceed the operating goals to support business demands.
Maintain proficiency to operate manufacturing equipment efficiently and effectively using MI/SCADA interfaces.
Maintain signature authority to perform area clear, line clearance and first articles.
Provide support and training to the production team for advanced troubleshooting of equipment.
Leverage statistical process software to maintain optimal process centering. Check equipment during production runs for proper performance and assures the group is maintaining standard speeds. Recommend changes in equipment that would benefit line performance.
Assist in creation and implementation of training/development plans for new equipment and assigned teammates. Provide feedback on design and operation of equipment to optimize manufacturing.
Assist in developing and revising manufacturing procedures and training programs for manufacturing employees.
Ensure overall team training is maintained current for processes and procedures relevant to all manufacturing/packaging activities and coordinate cross-training among roles to create staffing flexibility and increased depth
Assist in assignment of daily activities i.e.; scheduling production activities, breaks, lunches & Daily shift tie-in meetings.
Provide a level of mechanical, electrical and instrumentation understanding to assist Process Technicians and Maintenance personnel with routine problem solving.
Ensure the production of high quality products that are made with multiplicity of materials and assembled on a high-speed multifaceted production line. Ensure Quality Assurance is communicated to the team for minimal deviations and error free performance.
Review documentation to support manufacturing and maintenance history records to ensure adherence to FDA Regulations, GMP, ISO, Department Procedures and Manufacturing Directions. Ensure the most recent information related to manufacturing and maintenance is communicated and/or documented for compliance, history, and reliability.
Contribute to team goal development, status tracking and communication by providing feedback to the direct manager for the PMP (Performance Management Program) process.
Contribute to a positive team environment.
Assist in developing manufacturing teams
Inspire and motivate manufacturing team to achieve top performance as a team.
Inspire and promote self-growth and internal development within the team
Lead and promote continuous improvement through team and individual initiatives.
Identify areas of deficiency and implement practices to improve employee safety and to reduce the cost incurred through excessive scrap, poor workflow/process design and others.
Serve as a project team member to reduce scrapped lots/materials, increase product quality, decrease operational costs, and increase departmental efficiency/productivity.
Serve as change agent by driving the required cultural transformation and the adoption of successful process improvement practices. Diagnoses barriers to project success and facilitates resolution.
Provide assistance with the creation, review and revision of instructions and SOPs necessary for the Manufacture of VITEK 2 card products.
Lead manufacturing investigations, CAPA actions and other process and process equipment related quality concerns.
Utilize a variety of software systems to support daily work activities (i.e. MES, TrackWise, LiveLink/DocLink, SAP, Corhus, Compliance Wire etc.).
Oversee Manufacturing daily activities and/or performing the batch record review to ensure adherence to the appropriate departmental procedures and batch record release activities.
Perform line clearance, area clear and documentation verifications.
Ensure that all processes and procedures that are performed are documented in a timely manner in accordance with company and regulatory regulations.
Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all applicable regulatory policies/regulations.
Communicate information effectively and succinctly (facts, ideas, messages) and in an organized manner real-time.
Ty pical S t udies - E xp e r ie n ce, S ki l l s and Q ua l ific a t i o ns
Bachelor's degree in a life science, engineering or relevant field is required.
Minimum 6 years' experience in FDA regulated manufacturing environment and GMP is desired
Minimum of 6 years' experience maintaining and operating equipment is desired
Prior experience in a leadership role desired
Ability to routinely lift 20-40 pounds
Ability to stand for 8-12 hours
Ability to work overtime as required to cover a 24/7 operation
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.