API EM Principle Process Engineer

About the position

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. The position of API EM Process Engineer [Synthetic Peptide Synthesis and Purification / Small Molecule] reports to the API EM Engineering Associate Director and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always.

Responsibilities

• Develop and sustain process knowledge to ensure the execution of the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CMs).
• Assess the suitability of proposed equipment sets to ensure success of process validations.
• Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy.
• Participate with internal or CM resources in the equipment specification, procurement, and IQ/OQ/PQ.
• Engage with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets.
• Coach and Mentor Process Team Members.
• Utilize past experiences with unit operation control to provide insight and feedback to members of the CM Joint Process Team (JPT).
• Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions with CM members of the JPT.
• Support and peer review root cause analysis around FUME and operational incidents.
• Develop or support the capture of key process knowledge.
• Identify process knowledge gaps that impact equipment and process capability.
• Lead or participate in root cause analysis and countermeasure development and implementation for major safety, quality, or throughput incident investigations.
• Support development and technical analysis for ongoing continuous improvement activities.
• Create an appropriate methodology to ensure visibility of the ongoing state of qualification of key FUME systems at the CMs.
• Serve as the liaison for API EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) oversight at the relevant contract manufacturing sites.

Requirements

• 3 years of work experience in a manufacturing/process engineering related role.
• Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive chemical manufacturing experience.

Nice-to-haves

• Experience in typical unit operations for Large Molecule API Manufacturing.
• Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations.
• Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
• Demonstrated ability to function in a team environment as a technical leader and as a member of teams.
• Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
• Process Hazard Analysis experience.
• Successful application of root cause analysis and systematic problem solving.
• Strong Computer skills in a variety of software packages (e.g. Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite).

Benefits

• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).