Principal Process Engineer - API External Manufacturing; Molecule

Position Brand Description

The position of Principal Process Engineer – API EM Large Molecule reports to the API EM Engineering 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 by:

• Developing and sustaining process knowledge to ensure the execution of the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CMs)
• Assessment of 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
• FUME assessment to ensure an understanding of risk presented to the operational control strategy
• Participation with internal or CM resources in the equipment specification, procurement, and IQ/OQ/PQ
• Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact Lilly products
• Engaged with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets
• Adherence to the expectations of the Lilly Red Book when carrying out interactions 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

• Lead/support tech transfers and scale‑up from development through PV and commercial supply
• Translate process intent into operating strategies, equipment fit/gap, batch documentation, and PV readiness at CMs
• Support engineering runs and PV readiness through parameter optimization and performance trending

• 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 such as 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…