Engineering Associate Director (AD) - Device Assembly

About the role

The Engineering Associate Director (AD)- Device Assembly is responsible for the staffing, training, and leadership of the engineering group (both process, automation and maintenance) supporting asset delivery, process development, commissioning, qualification, validation and startup of the packaging lines in the site expansion project.

Responsibilities

• Manage for Results / Strategic Planning:
  • Manage Engineering and Maintenance support for Commercial Manufacturing Operations
  • 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.
  • Prioritize teams work to optimize equipment output and impact, ensuring proactive and continuous improvement mindset for process and operational improvements and optimization.
  • 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.
• Leadership:
  • This position involves direct management of 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.
  • Maintain compliance with quality requirements. (trainings, CAPA, deviations)

Requirements

• Bachelor's degree in engineering
• At least 7 years process engineering experience
• Previous management or leadership experience including leading or working effectively with a cross functional group
• Strong experience in equipment optimization, reliability and troubleshooting
• 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.

Qualifications

• Strong technical aptitude and ability to train and mentor others

Skills

• Statistical thinking and data analysis methods to understand process variability and capability to drive improvements

Benefits

Up to 20% travel and more can be expected during the startup phase.

Required to be on call, as applicable.

Shift work may apply.

Pay

$123,000 - $198,000

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).