Senior/Principal Process Engineer

Role Summary

Senior/Principal Process Engineer to support the ATMP manufacturing startup in Lebanon, IN, enabling GMP manufacturing of advanced therapy medicinal products. You will contribute to facility startup, qualification, process transfer, and ongoing operation across batch and continuous API production, developing and implementing process control strategies and qualification plans. You will collaborate with Lilly's Global Facility Delivery team to ensure right-first-time startup and to establish an integrated Operational Readiness plan that enables a successful GMP startup.

Responsibilities

• Provide Process Engineering support to the Global Facility Delivery team with a strong focus on right first time and on schedule facility start-up (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 integrated Operational Readiness Plan (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.
• 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.

Qualifications

• Required: Bachelor's Degree in Chemical, Biochemical, Pharmaceutical, Biomedical, or Mechanical Engineering
• Required: 3+ years of relevant experience in manufacturing operations (prefer chemical, pharmaceutical)
• Required: Authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.
• Preferred: Deep technical interest and understanding in Chemical Engineering
• Preferred: Experience in ATMP manufacturing
• Preferred: Strong analytical and problem solving skills
• Preferred: 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
• Preferred: Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented
• Preferred: Guidance/mentoring of others through processes
• Preferred: Flexibility to meet business needs