Manufacturing Team Lead - Night Shift at bioMerieux

Benefits at bioMerieux:
Low-cost medical, dental, and vision benefits starting day one.
11 paid holidays
160 hours of paid time off
Annual bonus
9.5% 401k company contribution with no vesting period
Tuition reimbursement up to $10,000 per calendar year
Onsite cafeteria with daily food stipend 

Position Summary:

Normal working hours for this role are 7:00pm - 7:30am working a 2-2-3 rotation schedule. 

The Team Lead position is responsible for front-line leadership of a team engaged in the operation of high speed manufacturing/packaging equipment and/or process-driven Reagent formulation.  The Team Lead position includes all aspects of production/packaging and maintenance work including reagent formulation, inspecting, maintenance, cleaning, troubleshooting and repair of manufacturing/process equipment.  The Team Lead position develops employees by providing feedback to its direct manager to assist in thorough effective personnel performance management and driving accountability for team performance metrics and projects.  The ability to effectively lead quality initiatives is critical to the department’s ability to improve manufacturing processes, increase product quality, improve departmental productivity/efficiency, and above all, reduce manufacturing costs/scrap.

Primary Responsibilities:

• Understand the machine operation and how it translates to the manufacturing processes.
• Provide feedback on design and operation of equipment to optimize manufacturing.
• Assist in developing and revising manufacturing procedures and training programs for Manufacturing employees. 
• Assist in creation and implementation of training/development plans for new equipment and assigned teammates.
• 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 management of daily activities i.e; scheduling production activities & Daily shift tie-in meetings.
• Assist in maintaining an efficient and effective workforce. Maximize equipment and process capabilities. Maintaining the BacT/ALERT manufacturing operation so that it is GMP compliant and meets FDA and ISO requirements.  Maximize productivity with a goal of operating the manufacturing equipment to meet and exceed the Operating Equipment Efficiency (OEE) goals determined by World Class Manufacturing standards to support business demands.
• Provide a level of mechanical, electrical and instrumentation understanding to assist Process Technicians and Maintenance personnel with routine problem solving. 
• Provide support and training to the production team for advanced troubleshooting of high speed automated equipment.
• 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, maintenance history records and training requirements that adhere 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.
• Develop manufacturing team
• 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 BacT/ALERT products.
• Assist with Manufacturing investigations, CAPA actions, IPEs and other process equipment related quality concerns.
• Utilize a variety of software systems to support daily work activities (i.e. TrackWise, LiveLink/DocLink, SAP, BRAM, Corhus, 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.
• 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.
• Must be able to demonstrate flexibility around changing priorities.
• Effectively communicate information (for example, facts, ideas, or messages) in a succinct and organized manner real-time.
• Conducts staff meetings daily or as needed, keeping records/documentation of that discussed.
• Perform other duties as assigned by Management

Education, Skills, & Experience: