
Sr Director - Device Assembly and Packaging Operations
- Pleasant Prairie, WI
- Permanent
- Full-time
- Provide Health, Safety and Environmental (HSE) and Quality leadership for the DAP operational and flow team.
- Support Site Leadership to build a diverse and capable site organization based in engineering first principles and operational excellence. Talent management, development, and retention within the Kenosha organization (and beyond).
- Provide operational technical leadership and develop objectives to deliver Business and Strategic Plan Goals as it relates to safety, quality, and equipment/process effectiveness and efficiency.
- Represent operational capabilities beyond the Lilly Kenosha site (e.g. other Lilly sites and global functional groups).
- Partner with Technical Services, Quality, Engineering and Tech@Lilly leadership to deliver operational results.
- Actively engage team and deliver significant capital and technological projects.
- Deliver equipment, lines, and supporting systems through user requirements, design, build, verification, qualification, validation, and subsequent operation.
- Develop local processes and procedures for the operational function.
- Ensure practice matches procedure.
- Ensure the functions are aligned and driven to meet production throughput goals including daily operation of the manufacturing lines, deviation and change management, variability reduction, and equipment/system reliability.
- Champion continuous improvement.
- Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
- Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
- This role has direct interaction with Regulatory Agencies during site inspections.
- Understand and influence the manufacturing control strategy for device assembly, and packaging.
- Bachelor's Degree in Engineering, a Life Science, or Business/Operations
- At least 10 years of experience at a manufacturing site
- At least 5 years previous management or leadership experience including leading or working effectively with a cross-functional group.
- Including leading or working effectively with a cross functional group
- Front line experience in device assembly and or packaging operations
- Solid understanding of basic requirements of regulatory agencies
- Previous facility or area start up experience
- Previous experience in operations and engineering
- Previous experience with highly automated equipment
- Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
- Previous equipment qualification and process validation experience
- Previous experience with Manufacturing Execution Systems and electronic batch release.
- Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs
- Previous experience with deviation and change management systems including Trackwise