Process Engineer

Senior Principal Process Engineer

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.

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 modeling, 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

Additional Skills / Preferences

Additional Information