Engineering Associate Director (AD) - Device Assembly

Eli Lilly and Company • Pleasant Prairie, WI

3d • Onsite

About The Position

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, Device Assembly Packaging Operations, Warehouse and Logistics, Site Utilities.
• 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 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.
• 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