Principal Process Engineer – Filling

Eli Lilly and Company • Pleasant Prairie, WI

8h

About The Position

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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism The principal process engineer - Filling plays a critical role as a technical leader and Subject Matter Expert in sterilization, aseptic filling, sealing and handling of sterile drug product to ensure manufacturing processes operate safely, efficiently and in compliance with regulatory standards. Process Ownership and Equipment Reliability Use data to track performance and guide decisions. Utilize optimization resources and tools for process analysis and process improvement studies. Ensure systems remain in a qualified state and are appropriate for use. Ensure maintenance and calibration activities are established and periodically reviewed for trends – generate action plans for improvements, if needed. Ensure maintenance and calibration activities are established and periodically reviewed Apply statistical thinking and methods to understand process variability and capability, and establish/drive improvements, accordingly. Technical Leadership Assist with and review documents related to key learning points, technical analyses, and investigations of incidents. Guide engineers in process expertise, problem-solving, critical thinking, project management, design and excellence in execution. Review and approve documentation/decisions requiring “responsible” engineer level of authority. Lead or participate in root cause analysis and countermeasure development and implementation of major safety, quality, or throughput incident investigations. Performs review of incident documentation for technical accuracy. Identify process bottlenecks and assist in prioritization of opportunities with respect to overall business objectives. Regulatory and Audit Readiness Act as a key contact during audits (quality, HSE), ensuring adherence to regulatory requirements and site inspection readiness. Project Leadership Develop project scopes for both short- and long-term capital projects, serving as user representative or project manager when needed. Sponsor and manage technology transfers, and improvement initiatives from concept through execution. Technical Performance and Continuous Improvement Lead or assist with root cause analysis and countermeasure implementation for major safety, quality, or throughput incidents. Review incident documentation for technical accuracy. Support development and technical analysis for long term large-scale initiatives such as productivity improvements, GMP remediation, and safety risk mitigation. Review and track key process engineering metrics. Mentorship and Development Coach junior engineers, promote standardization of technical procedures, and foster alignment with global engineering principles. Support development of training and training material for cross-functional teams including operations, QA, MSAT

Requirements

• Bachelor’s degree in engineering
• 10+ years senior engineering experience in a parenteral manufacturing site
• 5+ years of aseptic filling operation experience
• Solid understanding of basic requirements of regulatory agencies
• Product Tech transfer experience
• Equipment trouble shooting experience
• Previous facility or area start up experience
• Prior experience working effectively with a cross functional group including network and/or global functions
• Excellent interpersonal, written, and oral communication skills
• Strong technical aptitude and ability to train and mentor others
• Ability to handle multiple competing priorities

Nice To Haves

• Previous experience for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Previous experience with highly automated equipment
• Previous experience with Optima PFS lines
• Previous equipment qualification and process validation experience
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• Previous experience with CMMS systems
• Previous experience with deviation and change management systems including Trackwise

Responsibilities

• Process Ownership and Equipment Reliability Use data to track performance and guide decisions.
• Utilize optimization resources and tools for process analysis and process improvement studies.
• Ensure systems remain in a qualified state and are appropriate for use.
• Ensure maintenance and calibration activities are established and periodically reviewed for trends – generate action plans for improvements, if needed.
• Ensure maintenance and calibration activities are established and periodically reviewed Apply statistical thinking and methods to understand process variability and capability, and establish/drive improvements, accordingly.
• Technical Leadership Assist with and review documents related to key learning points, technical analyses, and investigations of incidents.
• Guide engineers in process expertise, problem-solving, critical thinking, project management, design and excellence in execution.
• Review and approve documentation/decisions requiring “responsible” engineer level of authority.
• Lead or participate in root cause analysis and countermeasure development and implementation of major safety, quality, or throughput incident investigations.
• Performs review of incident documentation for technical accuracy.
• Identify process bottlenecks and assist in prioritization of opportunities with respect to overall business objectives.
• Regulatory and Audit Readiness Act as a key contact during audits (quality, HSE), ensuring adherence to regulatory requirements and site inspection readiness.
• Project Leadership Develop project scopes for both short- and long-term capital projects, serving as user representative or project manager when needed.
• Sponsor and manage technology transfers, and improvement initiatives from concept through execution.
• Technical Performance and Continuous Improvement Lead or assist with root cause analysis and countermeasure implementation for major safety, quality, or throughput incidents.
• Review incident documentation for technical accuracy.
• Support development and technical analysis for long term large-scale initiatives such as productivity improvements, GMP remediation, and safety risk mitigation.
• Review and track key process engineering metrics.
• Mentorship and Development Coach junior engineers, promote standardization of technical procedures, and foster alignment with global engineering principles.
• Support development of training and training material for cross-functional teams including operations, QA, MSAT

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees