Sr. Principal/Advisor - API Process Engineer at Eli Lilly and Company

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.

Job Description

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 advanced manufacturing facility for production of API 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 Senior Principal 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

The Senior Principal Process Engineer provides technical leadership and expertise for production operations in the areas of: coaching and mentoring front line process engineers, developing and sustaining process knowledge, process and equipment support, process optimization, equipment qualification, equipment capability and asset management, and engineering business systems.  This role will support production operation in small molecule or peptides manufacturing.  

Key Deliverables: 

• Coach and mentor front line process engineers in all aspects of fundamental engineering activities for batch API supply or continuous platforms.
• Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions based on first principles. 
• Support and peer review root cause analysis for equipment and operational events and other technical documents. 
• Identify process knowledge gaps that impact equipment and process capability. 
• Develop or support the capture of key process knowledge (material and energy balances, kinetics, chemistry, equipment design basis, etc).
• Support, develop and maintain the basis of safety for process equipment.
• Provide engineering support for Process Safety Management (PSM) and Process Hazard Reviews (PHRs).
• Review the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose.
• Ensure that changes, maintenance and other interventions do not adversely impact the qualification state of the 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.
• Provide technical oversight of ongoing equipment qualification requirements. 
• Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose. 
• Provide guidance in development of test plans for Verification packages and associated critical components. 
• Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance. 

Basic Qualifications

• Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline
• 5+ years of experience in API Manufacturing Unit 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.
• Ability to coach others for development of technical knowledge and skills. 
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
• Guidance/mentoring of others through processes.
• Flexibility to meet business needs.

Additional Information:

• Potential for travel (less than 20% - could be domestic and/or international)

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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