Senior/Principal Process Engineer

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.

Lilly is currently constructing an advanced manufacturing facility for production of advanced therapy medicinal products (ATMPs) located in Lebanon, IN.  This facility is intended to provide current and future products, including new modalities.  This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. 

We are seeking Process Engineers to support the ATMP Manufacturing Business in Lebanon.  Process Engineering is core to delivering our product pipeline across batch and continuous API production and development.

Responsibilities

Facility Start-up:

• Provide Process Engineering support to the Global Facility Delivery team (Lilly’s Global Large Scale Capital Delivery Team) with a strong focus on right first time and on schedule facility start-up (e.g. design reviews, process safety assessments, User Requirements, C&Q support, unit operation shakedown and startup, facility operational readiness) 

• Define and own relevant aspects of the overall integrated Operational Readiness Plan (e.g. SOP development, maintenance strategy, automation optimization, pre-startup safety reviews, alarm requirements, Performance Qualification requirements/protocol development, etc.) 

• Own the Performance Qualification execution for area of responsibility 

• Develop and implement unit operation and equipment control strategy to sustain and optimize API processes.

• Support initial Operations Training requirements as the Equipment and Area SME 

• Lead/support the tech transfer of new processes into the facility 

Facility Operations:

• Provide process engineering support in batch API supply or continuous platforms through application of chemical engineering fundamentals.

• Monitor, assess and document equipment performance to maintain ongoing qualification.

• Develop and maintain the basis of safety for process equipment.

• Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control.

• Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team.

• Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms.

• Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions.

Basic Qualifications

• Bachelor's Degree in Chemical, Biochemical, Pharmaceutical, Biomedical, or Mechanical Engineering

• 3+ years of relevant experience in manufacturing operations (prefer chemical, pharmaceutical)

Additional Skills/Preferences

• Deep technical interest and understanding in the field of Chemical Engineering.

• Experience in ATMP manufacturing.

• Strong analytical and problem solving skills.

• Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals.

• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.

• Guidance/mentoring of others through processes.

• Flexibility to meet business needs.

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