Lead Process Engineer

2 weeks ago

Lebanon, Indiana, United States Eli Lilly Full time

Company Overview
At Eli Lilly, we are dedicated to merging compassion with innovation to enhance the quality of life for individuals globally. As a prominent player in the healthcare sector, our headquarters is situated in Indianapolis, Indiana.

Our global workforce is committed to discovering and delivering transformative medications to those in need, advancing the comprehension and management of diseases, and contributing to our communities through charitable initiatives and volunteer efforts.

We prioritize excellence in our endeavors and place people at the forefront of our mission. We seek individuals who are resolute in their commitment to improving lives worldwide.

Position Overview
For over a century, Eli Lilly has been at the forefront of manufacturing pharmaceuticals that enhance lives globally. Our production facilities utilize cutting-edge manufacturing technologies and adhere to stringent quality standards.

The Manufacturing division at Eli Lilly is committed to excellence in its processes, standards, and behaviors, ensuring that safety and quality are paramount in the development of our medicines.

We are in the process of establishing a state-of-the-art manufacturing facility for the production of Active Pharmaceutical Ingredients (APIs) in Lebanon, IN. This facility represents a significant investment in our manufacturing capabilities and is designed to supply APIs for both current and future products, including innovative modalities.

This role presents a unique opportunity to join the startup team for a new manufacturing site, where the successful candidate will play a crucial role in developing the processes and infrastructure necessary for a successful transition to Good Manufacturing Practice (GMP) operations.

Key Responsibilities

  • Facility Start-up: Provide process engineering support to the Global Facility Delivery team, focusing on achieving timely and accurate facility start-up, including design reviews, process safety assessments, and operational readiness.
  • Define and manage critical components of the integrated Operational Readiness Plan, including Standard Operating Procedure (SOP) development, maintenance strategies, and performance qualification protocols.
  • Lead the execution of Performance Qualification for assigned areas of responsibility.
  • Develop and implement strategies for unit operations and equipment control to optimize API processes.
  • Support initial training requirements for operations as the Subject Matter Expert (SME) for equipment and areas.
  • Facilitate the transfer of new processes into the facility.

Facility Operations:
Provide ongoing process engineering support for batch API supply or continuous platforms by applying chemical engineering principles. Responsibilities include:

  • Monitoring and documenting equipment performance to ensure continuous qualification.
  • Developing and maintaining safety protocols for process equipment.
  • Integrating mechanistic modeling and process simulation to enhance understanding and control of processes.
  • Identifying and implementing continuous improvement initiatives as a key member of a cross-functional team.
  • Utilizing root cause analysis to address process and equipment challenges, delivering sustainable corrective actions.

Qualifications

  • Bachelor's Degree in Chemical, Biochemical, Bioprocess, Process, or Mechanical Engineering.
  • A minimum of 5 years of relevant experience in chemical or pharmaceutical manufacturing operations.

Preferred Skills

  • Strong technical knowledge and interest in Chemical Engineering.
  • Excellent analytical and problem-solving abilities.
  • Capability to work independently and collaboratively within a diverse team of professionals.
  • Creativity in identifying improvement opportunities and the determination to implement them.
  • Experience in Process Safety Management (PSM) or GMP manufacturing environments.

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