- This individual is responsible for organizing continuous improvement on the Reagent Manufacturing floor. As organizer, this individual will manage a team of coordinators as well as work closely with a cross-functional team including Manufacturing Operations, Engineering, Maintenance and Quality Assurance to prioritize, resource, and execute Continuous Improvement initiatives.
- This individual is responsible for implementing standard tools and practices for Continuous Improvement including Lean, 6S, Red Tag, Kaizen, and problem solving.
- This individual interfaces with other business leaders both at this site and other Biomerieux sites to organize, standardize and facilitate Continuous Improvement efforts.
- This individual will oversee Manufacturing Support efforts on the manufacturing floor. This consists of developing relevant KPIs by work center and organizing a support team consisting of operations, maintenance, engineering and safety to review and track projects to improve manufacturing performance per those KPIs.
This position reports to the Senior Director of Reagent Manufacturing Support and interacts with senior members of the BFDX’s Reagent Manufacturing Operations, Engineering, QA, Materials Management, and Facilities teams.
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BFDX’s Quality System.
- Works closely with operations management and operations support teams (including, but not limited to, Maintenance, Engineering, Quality Assurance, Safety and Technology Transfer) to develop tactics that help operations achieve their KPIs.
- Works closely with the operations management team as well as the appropriate business systems to generate standardized reporting for operational metrics that will be used in Management Review as well as drive Continuous Improvement.
- Review personnel performance and compensation. Responsible for all hiring decisions within the team including obtaining new job approvals.
- Organize and lead a team of Engineers and subject matter experts to trouble shoot non-conforming product.
- Organize and lead department safety meetings.
- Present CI metrics at Management Review meetings.
- Trains team on methods of continuous improvement practices including Lean, 6S and Kaizen.
- Responsible for standardizing 6S, Red Tag, and other administrative policies/guidelines in the Reagent Manufacturing spaces.
- Point of contact for Continuous Improvement initiatives on the Reagent Manufacturing floor.
- Responsible for creating and maintaining the Value Stream Map of Reagent Manufacturing.
- Works with project teams for optimize work-flow for onboarding new manufacturing equipment.
- Promotes QSR compliance in all assigned tasks.
- Maintains oversight of equipment deliveries to ensure that contamination prevention procedures are appropriately followed.
- Serves as the area representative for the Safety and Security team, BERT teams, and other facilities or safety requirements. Acts as liaison to implement policies and procedures from the facilities department to the departments occupying the manufacturing spaces.
- Manages best practices for operational excellence within the manufacturing division.
- Other duties as assigned.
Training and Education:
A degree in a Life Science, Engineering or Manufacturing/Business Operations. Certifications in Lean, Six Sigma, and/or APICS.
Minimum of 2 years in an FDA/ISO manufacturing environment with a minimum of 3 years in a leadership role. Knowledge of and experience implementing continuous improvement principles. Knowledge of real time PCR is preferred. Experience in Industry and Knowledge of GMP/QSR/ISO is also preferred.
Well-developed managerial skills including: Computer literacy in database, spreadsheet, project and word processing software. Ability to write reports and manufacturing procedures. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to organize, lead and evaluate the work of other personnel required. Ability to develop, coordinate and implement multi-level individual and team-based tasks. Well-developed interpersonal communication skills.
- Comprehensive understanding of industry regulations and cGMP compliance
- Demonstrated understanding of Kaizen, 5s, and Lean Manufacturing principles
- Experience in PCR based medical device-systems
- Experience in high throughput manufacturing
- Strong problem-solving skills and attention to detail
- Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization
- Demonstrated organizational and mentoring skills.
- Ability to work independently with minimal supervision.
- Ability to manage numerous priorities simultaneously
- Ability to shift priorities to meet required deadlines
- Effectively communicate issues cross-functionally in a timely manner
- Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.
Must be able to safely lift and maneuver up to 50 lbs. and perform duties while wearing a PAPR.