Associate Director - Engineering - Packaging Operations
Scorpion Therapeutics, Pleasant Prairie, Wisconsin, United States, 53158
Role Summary
The Engineering Associate Director - Packaging Operations will lead the engineering group (process, automation, and maintenance) supporting asset delivery, process development, commissioning, qualification, validation, and startup of the packaging lines for Lilly’s Kenosha site expansion. After startup, the role will oversee day-to-day engineering activities and plan for the 3-6 month horizon, providing coaching in safety, quality, engineering, optimization, and continuous improvement. Location: Kenosha, Wisconsin. Responsibilities
Lead and manage the engineering and maintenance team delivering front-line support across areas including Parenteral Operations, Device Assembly, Packaging Operations, Warehouse and Logistics, Site Utilities, BMS, and Chambers. Ensure technical and maintenance support for manufacturing or utilities processes in the assigned area. Guide SMEs that coach Front Line Engineers and drive equipment reliability, uptime, continuous improvements, and capital delivery. Make decisions based on engineering standards, policies, procedures and business plans that impact the team's ability to meet performance objectives. Provide functional leadership to engineering and maintenance representatives by coaching Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction. Lead, support and peer-review root cause analyses around equipment and operational events; support complex change controls and quality investigations with a strong root cause focus. Prioritize the team's work to optimize equipment output and uptime and foster a proactive, continuous improvement mindset for process and operational improvements. Apply statistical thinking and data analysis to understand process variability and drive improvement. Support regulatory inspections. Utilize control systems to monitor, trend, and verify equipment performance and downtime; identify opportunities to optimize cycle time, yield, loop tuning, and recipes. Support or lead troubleshooting to resolve equipment and operational problems; on-call hours may be required. Ensure compliance with environment, health, and safety requirements. Present and participate in Governance teams to represent engineering. Represent the group as technical SMEs on capital projects, supporting leading design, modifications, testing, qualifications, and associated documentation. Support commissioning and qualification activities. Direct management of front-line and SME engineering and maintenance team members; provide leadership, training, development, coaching and support to engineering staff. Engage and promote use of internal and external networks to help deliver sound technical decisions; promote first-principles thinking and engineering solutions. Monitor and ensure compliance with quality requirements (training, CAPA, deviations). Qualifications
Required: Bachelor's degree in engineering Required: At least 7 years of process engineering experience Preferred: Previous management or leadership experience including cross-functional leadership Preferred: Strong experience in equipment optimization, reliability and troubleshooting Preferred: Strong technical aptitude and ability to train and mentor others Preferred: Understanding of regulatory requirements (FDA, EMEA, DEKRA, OSHA) Preferred: Experience with highly automated equipment Preferred: Experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environments Preferred: Facility or area startup experience Preferred: Equipment qualification and process validation experience Preferred: Experience with Manufacturing Execution Systems and electronic batch release Preferred: Experience with Automated Storage and Retrieval System (ASRS) warehouses or AGVs Preferred: Experience with deviation and change management systems including TrackWise Education
Bachelor's degree in engineering Additional Requirements
Up to 20% travel during startup; more travel may be required. On-call availability as applicable. Shift work may apply.
#J-18808-Ljbffr
The Engineering Associate Director - Packaging Operations will lead the engineering group (process, automation, and maintenance) supporting asset delivery, process development, commissioning, qualification, validation, and startup of the packaging lines for Lilly’s Kenosha site expansion. After startup, the role will oversee day-to-day engineering activities and plan for the 3-6 month horizon, providing coaching in safety, quality, engineering, optimization, and continuous improvement. Location: Kenosha, Wisconsin. Responsibilities
Lead and manage the engineering and maintenance team delivering front-line support across areas including Parenteral Operations, Device Assembly, Packaging Operations, Warehouse and Logistics, Site Utilities, BMS, and Chambers. Ensure technical and maintenance support for manufacturing or utilities processes in the assigned area. Guide SMEs that coach Front Line Engineers and drive equipment reliability, uptime, continuous improvements, and capital delivery. Make decisions based on engineering standards, policies, procedures and business plans that impact the team's ability to meet performance objectives. Provide functional leadership to engineering and maintenance representatives by coaching Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction. Lead, support and peer-review root cause analyses around equipment and operational events; support complex change controls and quality investigations with a strong root cause focus. Prioritize the team's work to optimize equipment output and uptime and foster a proactive, continuous improvement mindset for process and operational improvements. Apply statistical thinking and data analysis to understand process variability and drive improvement. Support regulatory inspections. Utilize control systems to monitor, trend, and verify equipment performance and downtime; identify opportunities to optimize cycle time, yield, loop tuning, and recipes. Support or lead troubleshooting to resolve equipment and operational problems; on-call hours may be required. Ensure compliance with environment, health, and safety requirements. Present and participate in Governance teams to represent engineering. Represent the group as technical SMEs on capital projects, supporting leading design, modifications, testing, qualifications, and associated documentation. Support commissioning and qualification activities. Direct management of front-line and SME engineering and maintenance team members; provide leadership, training, development, coaching and support to engineering staff. Engage and promote use of internal and external networks to help deliver sound technical decisions; promote first-principles thinking and engineering solutions. Monitor and ensure compliance with quality requirements (training, CAPA, deviations). Qualifications
Required: Bachelor's degree in engineering Required: At least 7 years of process engineering experience Preferred: Previous management or leadership experience including cross-functional leadership Preferred: Strong experience in equipment optimization, reliability and troubleshooting Preferred: Strong technical aptitude and ability to train and mentor others Preferred: Understanding of regulatory requirements (FDA, EMEA, DEKRA, OSHA) Preferred: Experience with highly automated equipment Preferred: Experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environments Preferred: Facility or area startup experience Preferred: Equipment qualification and process validation experience Preferred: Experience with Manufacturing Execution Systems and electronic batch release Preferred: Experience with Automated Storage and Retrieval System (ASRS) warehouses or AGVs Preferred: Experience with deviation and change management systems including TrackWise Education
Bachelor's degree in engineering Additional Requirements
Up to 20% travel during startup; more travel may be required. On-call availability as applicable. Shift work may apply.
#J-18808-Ljbffr