Senior / Principal Process Engineer - APIEM

Utilize past experiences with unit operation control to provide insight and feedback to members of the Lilly / 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.

Practice vs procedure walk throughs at the CM sites

Periodic housekeeping / fit & finish walk-throughs with area management.

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 stay contemporary with key engineering disciplines and developing portfolio platforms (e.g. continuous manufacturing operations).

Review equipment and process system user requirements and qualification plans to ensure that the equipment and systems are appropriate for the intended purpose.

Act as customer representative for review of Contact Manufacturer (CM) requests for capital projects targeted at both short and long term needs.

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.

Leverage internal Lilly experts in HSE and PSM to ensure appropriate risk reduction at CMs.

Participate in Lilly HSE and PSM audits of contract manufacturing sites as applicable.

Maintain key HSE and PSM metrics for review within API EM.

Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of API contract manufacturing sites. These include, but are not limited to: Financial Responsibility and Reporting (FRAP); Lilly Red Book; Lilly contract manufacturing standards; Lilly engineering standards, and; Lilly Quality policies and best practices.

Experience in typical unit operations for Small Molecule API manufacturing or Peptide Synthesis/Purification manufacturing.

Develop and implement innovative approaches to problems

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).

Visualize an operation/process and reflect it in a model.

The normal schedule for this position is Monday-Friday, 8 hours/day. However, teleconferences may routinely occur outside of these hours due to the time zones of contract manufacturers. International travel may be required to support process start-ups, troubleshooting, and commercial manufacturing.

Must complete assigned training curriculum.

No certifications required.

Tasks require entering manufacturing and laboratory areas and will require wearing appropriate PPE.

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