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Lilly Principal Process Engineer - API Manufacturing in Lebanon, Indiana

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.

Overview

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for 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 API 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, Bioprocess, Process, or Mechanical Engineering

  • 5+ years of relevant experience in chemical or pharmaceutical manufacturing operations

Additional Skills/Preferences

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

  • 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.

  • Experience in PSM or GMP manufacturing facility.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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