Principal Process Engineer – Filling

Overview

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.

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.

• 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.

• Act as a key contact during audits (quality, HSE), ensuring adherence to regulatory requirements and site inspection readiness.

• 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.

• 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.

• 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

• 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

• 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

• Day Shift, possible after-hour support
• Project Delivery and/or Plant Shutdown may coincide with company holidays.
• Occasional travel may be required for training, conferences, capital projects, etc.

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