Associate Director - Engineering - Packaging Operations

Eli Lilly and Company • Pleasant Prairie, WI

5d • Onsite

About The Position

Lilly is entering an exciting period of growth and is committed to delivering innovative medicines to patients around the world. Lilly 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 the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Kenosha County site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

Requirements

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

Nice To Haves

• 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.
• Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment.
• Previous facility or area start up experience.
• 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.

Responsibilities

• Manage Engineering and Maintenance support for Commercial Manufacturing Operations.
• Manage 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 (i.e. Refrigerators, Incubators, Cold Rooms, etc.).
• 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 decision making based on engineering standards and 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 teams work to optimize equipment output and impact, ensuring 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 improvement.
• 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.
• Understand and ensure compliance with environment health & safety requirements.
• Present and attend various Governance teams to represent engineering.
• Represent group as technical SMEs on capital projects supporting/leading design, modifications, testing, qualifications, and associated documentation.
• Support commissioning and qualification activities.
• 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 principals with engineering staff, and drive engineering solutions for problems.
• Monitor and ensure compliance with quality requirements. (trainings, CAPA, deviations)

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager