Engineering Associate Director (AD) - Device Assembly
Eli Lilly and Company
August 23, 2026
On-site
Pleasant Prairie, WI
$123,000 - $198,000 USD yearly
Operations
Position: Engineering Associate Director (AD) – Device Assembly
Responsibilities:
- Lead staffing, training, and management of process, automation, and maintenance engineering teams supporting asset delivery, process development, commissioning, qualification, validation, and startup of packaging lines.
- After startup, support day-to-day engineering activities and plan for a 3–6 month horizon.
- Manage engineering/maintenance support for commercial manufacturing operations across: parenteral operations, device assembly, packaging operations, warehouse/logistics, and site utilities.
- Ensure technical/maintenance support, guide SMEs, and drive equipment reliability, uptime, continuous improvement, and capital delivery.
- Lead change management, deviations/investigations, equipment/process improvements, process controls, and variability reduction.
- Conduct/peer-review root cause analysis; support complex change controls and quality investigations.
- Use statistical thinking and data analysis to improve process variability/capability.
- Support regulatory inspections; monitor/trend/verify equipment performance and downtime; optimize cycle time, yield, tuning, and recipes.
- Lead/support troubleshooting with formal problem-solving techniques (on-call/off-hours as needed); ensure EHS compliance.
- Represent engineering in governance and serve as technical SME on capital projects; support commissioning and qualification.
Leadership:
- Directly manage front-line and SME engineering/maintenance team members; provide leadership, training, development, coaching; ensure quality compliance (training, CAPA, deviations).
Qualifications:
- Bachelor’s degree in engineering.
- At least 7 years of process engineering experience.
Preferred:
- Management/leadership experience; cross-functional leadership.
- Equipment optimization, reliability, and troubleshooting.
- Ability to train/mentor; automated equipment experience.
- Regulatory knowledge (FDA/EMEA/DEKRA/OSHA).
- Combination products/device assembly/pharma packaging/aseptic formulation and filling; facility/area start-up.
- Equipment qualification and process validation.
- MES and electronic batch release; ASRS/AGVs.
- Deviation and change management systems (e.g., Trackwise).
Other Information:
- Up to 20% travel (may increase during startup).
- On-call required; shift work may apply.
Responsibilities:
- Lead staffing, training, and management of process, automation, and maintenance engineering teams supporting asset delivery, process development, commissioning, qualification, validation, and startup of packaging lines.
- After startup, support day-to-day engineering activities and plan for a 3–6 month horizon.
- Manage engineering/maintenance support for commercial manufacturing operations across: parenteral operations, device assembly, packaging operations, warehouse/logistics, and site utilities.
- Ensure technical/maintenance support, guide SMEs, and drive equipment reliability, uptime, continuous improvement, and capital delivery.
- Lead change management, deviations/investigations, equipment/process improvements, process controls, and variability reduction.
- Conduct/peer-review root cause analysis; support complex change controls and quality investigations.
- Use statistical thinking and data analysis to improve process variability/capability.
- Support regulatory inspections; monitor/trend/verify equipment performance and downtime; optimize cycle time, yield, tuning, and recipes.
- Lead/support troubleshooting with formal problem-solving techniques (on-call/off-hours as needed); ensure EHS compliance.
- Represent engineering in governance and serve as technical SME on capital projects; support commissioning and qualification.
Leadership:
- Directly manage front-line and SME engineering/maintenance team members; provide leadership, training, development, coaching; ensure quality compliance (training, CAPA, deviations).
Qualifications:
- Bachelor’s degree in engineering.
- At least 7 years of process engineering experience.
Preferred:
- Management/leadership experience; cross-functional leadership.
- Equipment optimization, reliability, and troubleshooting.
- Ability to train/mentor; automated equipment experience.
- Regulatory knowledge (FDA/EMEA/DEKRA/OSHA).
- Combination products/device assembly/pharma packaging/aseptic formulation and filling; facility/area start-up.
- Equipment qualification and process validation.
- MES and electronic batch release; ASRS/AGVs.
- Deviation and change management systems (e.g., Trackwise).
Other Information:
- Up to 20% travel (may increase during startup).
- On-call required; shift work may apply.