Process Instrumentation Engineer - Lilly Medicine Foundry

Organization And Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Process Instrumentation Engineer is a key leader responsible for overseeing all process and utility instrumentation at The Medicine Foundry. This role ensures that all calibration activities are managed in compliance with phase appropriate GMP and other applicable standards. In addition, this role ensures alignment of calibration related programs and initiatives with organizational goals for safety, quality, and efficiency, directly supporting the delivery of novel medicines for clinical trials within The Medicine Foundry.

This position will be responsible for developing initial processes and requirements for the LMF site calibration program in alignment with the overall Engineering Technology Center (ETC) corporate standards. This position will also directly collaborate with the Process Engineering team in the preparation and selection of instrumentation for initial operation and overall instrument lifecycle. In addition, this position will work directly with the calibration supervisor and team of instrumentation technicians within the FUME Plant Engineering function in order to ensure critical and non-critical instrumentation is performed in accordance with planned specifications and use cases.

In line with the job outlined above, the following are typically the key tasks that would be expected of the role:

• Be the SME with a deep technical expertise in all instrumentation and calibration systems.
• Cross function collaboration with Global Facility Delivery (GFD) to support project delivery.
• Support C&Q activities, including but not limited to, initial calibrations, initial/operations verification, and/or equipment qualification.
• Provide field support to identify, troubleshoot, and resolve equipment issues.
• Ensure that the process instrumentation is in control, capable, and compliant to be used in the cGMP process.
• Provide discipline leadership to local projects to ensure proper instrument selection, qualification, documentation, and standardization.
• Make improvement recommendations to instrument calibration practices or instrument shop standards to ensure that measurements are compliant with corporate standards.
• Manage measurement and control equipment obsolescence.
• Perform continuous improvement of our assets spare parts list for accuracy.
• Contribute to incident/deviation investigations on instrumentation and implement countermeasures as appropriate to prevent reoccurrence.
• Own change controls, when applicable, to increase the robustness and reliability of instrumentation.

• Bachelor’s degree in Engineering (prefer ME, MET, EE)
• 5+ years of industrial process instrumentation or calibration experience, FDA regulated industry preferred.
• Strong understanding of process instrumentation calibration, including the following:
  • Instrumentation (pressure, temperature, flow, level, pH)
  • Electrical test equipment (flukes, signal generators, oscilloscopes, etc.)
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

• Previous start up experience for new building and site process instrumentation.
• Previous equipment installation / commissioning / qualification experience.
• Engineering experience with manufacturing plant instrumentation.
• Engineering related project management experience.
• Experience with CMMS (Computerized Maintenance Management Systems), U/BMS (Utility/Building Management Systems) and QMS (Quality Management Systems).
• Demonstrated office software…