Senior​/Principal Process Engineer - APIEM

Senior / Principal Process Engineer - APIEM

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 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 Engineer [Synthetic Peptide Synthesis and Purification] reports to the API EM Engineering Associate Director and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel to reliably supply and commercialize medicines with safety first and quality always.

Key responsibilities include:

• Developing and sustaining process knowledge to ensure the execution of product, process, and operational control strategies at Contract Manufacturers.
• Direct and indirect interaction with CM personnel to ensure reliable supply via CM execution of operational control strategy.
• FUME assessment to understand risk presented to operational strategy.
• Participation with internal or CM resources in equipment specification, procurement, and IQ/OQ/PQ.
• Assessment of HSE and PSM elements of the CM that impact Lilly products.
• Engagement with internal and external resources to develop capabilities with new or evolving technologies.
• Adherence to the expectations of the Lilly Red Book when interacting with API EM’s CMs.

• 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.
• Peer review documentation of learning points, technical studies, and incident investigations.

• Identify process knowledge gaps that impact equipment and process capability.
• Develop or support the capture of key process knowledge (examples include material and energy balances, kinetics, chemistry, process modeling, and equipment design basis).
• Enable the development and maintenance of process knowledge infrastructure such as key models, report history, lab models, and literature.
• Utilize optimization resources and tools for process analysis and process improvement studies.
• Review and track key process engineering metrics.

• Identify systemic issues affecting production and reliable supply from CMs.
• Lead or participate in root cause analysis and countermeasure development and implementation for major safety, quality, or throughput incident investigations. Perform reviews of incident documentation for technical accuracy.
• Review and approve documentation and engineering decisions.

• Support development and technical analysis for on‑going continuous improvement activities.
• Review and identify cost reduction opportunities, as well as process capacities and bottlenecks. Assist in prioritization of opportunities with respect to overall business objectives.
• Work with the CMs to ensure the application of statistical thinking and methods to understand process variability and capability.
• Perform and promote optimization of unit operation cycle time, loading, and yield performance.
• Engage with late phase development and Engineering Technical Center resources to ensure staying contemporary with key engineering disciplines and developing portfolio platforms (e.g., continuous manufacturing operations).

• Create an appropriate methodology to ensure visibility of the ongoing state of qualification of key FUME systems at the CMs.
• Review equipment and process system user requirements and qualification plans to ensure that the equipment…