Engineering Associate Director (AD)- Device Assembly

About

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

Lilly is entering an exciting period of growth and is investing over $3 billion to create a new state‑of‑the‑art manufacturing site in Kenosha, Wisconsin. The brand‑new facility will utilize the latest technology to increase manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. The Engineering Associate Director (AD) – Device Assembly will lead the engineering group (process, automation, and maintenance) supporting asset delivery, process development, commissioning, qualification, validation and startup of the packaging lines in the site expansion project, and will continue to support day‑to‑day engineering activities after startup.

Responsibilities

• Manage Engineering and Maintenance support for Commercial Manufacturing Operations.
• Lead a team of process and automation engineers and maintenance technicians providing Front Line support in one or more of the following areas:
  • Parenteral Operations (Parts Washers, Autoclaves, Formulation, Isolator – Syringe Filler, Automated Visual Inspection)
  • Device Assembly
  • Packaging Operations
  • Warehouse and Logistics (Autonomous Guided Vehicles, Automatic Storage and Retrieval System, etc.)
  • Site Utilities (HVAC, Steam Water, Gases, etc.), BMS, Chambers (e.g., Refrigerators, Incubators, Cold Rooms)
• Ensure appropriate technical and maintenance support for manufacturing or utilities processes of the assigned area.
• Guide SMEs that will provide coaching/assistance to Front Line Engineers and drive increased equipment reliability and uptime, continuous improvements, support capital delivery, among other key strategic initiatives.
• Understand, ensure, and make decisions based on engineering standards, policies, procedures and business plan that impact the ability of the team members to meet performance objectives.
• Provide functional leadership to engineering and maintenance representatives by coaching the following business processes: Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction.
• Lead, support and peer‑review root cause analysis around equipment and operational events; support complex change controls and quality investigations with strong root cause analysis focus.
• Prioritize team work to optimize equipment output and impact, ensuring a proactive and continuous‑improvement mindset for process and operational improvements and optimization.
• Apply statistical thinking and data analysis methods to understand process variability and capability to drive improvements.
• Support regulatory inspections.
• Utilize control systems to monitor, trend and verify equipment performance and downtime; identify and optimize unit operation cycle time, yield performance, loop tuning, recipes, etc.
• Support or lead troubleshooting efforts to resolve equipment and operational problems and ensure formal problem‑solving techniques are appropriately utilized (on‑call/off‑hours support required).
• Understand and ensure compliance with environment health & safety requirements.
• Present and attend various 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.

Leadership

• Directly manage front‑line & SME engineering and maintenance team members.
• Provide leadership, training, development, coaching and support of engineering team members.
• Engage and promote use of internal and external networks and partnerships to help deliver sound technical decisions.
• Promote use of first principles with engineering staff and drive engineering solutions for problems.
• Monitor and ensure compliance with quality requirements (trainings, CAPA, deviations).

Requirements

Basic Requirements

• Bachelor’s degree in engineering
• At least 7 years process engineering experience

Additional Preferences

• Previous management or leadership experience, including leading or working effectively with a cross‑functional group
• Strong experience in equipment optimization, reliability and troubleshooting
• Strong technical aptitude and ability to train and mentor others
• Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA
• Previous experience with highly automated equipment
• Experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
• Facility or area start‑up experience
• Equipment qualification and process validation experience
• Experience with Manufacturing Execution Systems and electronic batch release
• Experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs
• Experience with deviation and change management systems including Trackwise

Other Information

• Up to 20 % travel and more can be expected during the startup phase.
• Required to be on call, as applicable.
• Shift work may apply.

Compensation & Benefits

• Anticipated wage: $123,000 – $198,000 (actual compensation depends on education, experience, skills, and geographic location).
• Eligible for a company bonus (based on company and individual performance).
• Comprehensive benefit program includes:
  • Company‑sponsored 401(k) and pension
  • Vacation benefits
  • Medical, dental, vision, and prescription drug coverage
  • Flexible benefits (e.g., healthcare and/or dependent day‑care flexible spending accounts)
  • Life insurance and death benefits
  • Various time‑off and leave‑of‑absence benefits
  • Well‑being benefits (employee assistance program, fitness benefits, employee clubs and activities)

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Lilly is an EEO employer and is committed to providing equal opportunity for individuals with disabilities.