Drug Substance Process Engineer - Advanced Therapies Manufacturing

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 35,000 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 innovative facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a new manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

Main Purpose and Objectives of Position:

The Drug Substance Process Engineer provides technical guidance of the process equipment and is responsible for ensuring that the equipment remains in a qualified state in order to support the manufacture of bulk drug substance.

Key Responsibilities:

Process and Equipment Support:

• Equipment owner integrating process, process safety, environmental requirements and equipment knowledge.
• Monitor established equipment systems for process indicators to identify potential issues affecting production.
• Investigate and resolve equipment performance issues.
• Technical expert/support for installation and maintenance of process equipment, new technologies and equipment improvements.
• Develop training / tools for operations to transfer knowledge of equipment capabilities and operational techniques to operations and maintenance.

Improving the Business or Process:

• Identify/Implement improvement projects for capacity, product quality, raw material cost, emissions/waste loads, process variability and process safety.
• Perform and summarize improvement opportunities in technical reports.
• Understand process/unit capacity constraints.
• Lead or participate in equipment/process qualification activities (including commissioning activities of new equipment or areas).

Health, Safety and Environmental Management:

• May provide the technical leadership and problem-solving skills for Health, Safety and Environmental incident investigations.
• Lead and/or participate in process hazard reviews and other process safety activities, main resource for process safety issues on supported processes.

Alignment to Business Systems:

• Manage the implementation of countermeasures arising from deviations, and safety related events.
• Manage the implementation of recommendations from PHRs and other audit findings.
• Maintain training compliance.
• Maintain and establish the equipment technical information for the process such as Equipment procedures, P&IDs, Equipment information in PFDs.

Basic Requirements:

• Bachelor of Science Degree in Engineering.

What you should bring to the team:

Specifically, during the construction and startup phase of the Lebanon Plant 2 (LP2) site (2023 to 2025) the process engineer will be expected to be a collaborative, inclusive and energetic team member and support the broader LP2 team to:

• Develop and implement the systems and processes needed to run the manufacturing area, using existing Lilly knowledge and practices where necessary, but also incorporating external experiences and learning.
• Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach.
• Support the project team as they deliver the facility to the site team, by providing feedback and support on decisions & design considerations etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and successful startup.
• Ability to apply fundamental engineering principles to process understanding, problem solving and process improvement.
• Ability to function in a team environment.
• Effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
• Available on call to address processing emergencies over the phone and at times return to the plant during off-hours.

Additional Preferences:

• Experience in API or Drug Substance manufacturing - biotech/monoclonal or Cell and Gene Therapy preferred.
• Startup, commissioning or commercialization experience preferred.
• Experience with Change Management, Deviation Management, Periodic Reviews, Commissioning and Qualification, Routine Data Monitoring.
• Ability to apply statistical thinking concepts to the analysis of manufacturing processes.
• Visualize an operation/process and reflect it in a model.
• Root cause analysis and the problem solving.
• Process Hazard Identification/ Mitigation Skills.
• Strong Computer skills in a variety of software packages (Batch Plus, JMP, Visio, PI Data Historian, MS Project, Excel).
• Experience with normal processing equipment/unit operations.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).