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This position is part of the Bioprocess Development (BR&D) organization. The individual in this role will be responsible for upstream process equipment supporting a Clinical Trials Manufacturing Facility. They will interface with development and operations for tech transfer activities and serve as the main contact for troubleshooting any equipment issues.

Responsibilities:

The bioprocess pilot plant contains both stainless steel and single-use equipment to support several different clinical trial manufacturing processes. The individual in this role provides engineering support to the maintenance and operations groups as needed to maintain production of Bulk API for development and clinical trial purposes. The individual in this role has the following responsibilities:

• Provide engineering support in the pilot plant, e.g., troubleshoot process and equipment issues, lead process equipment change controls, and lead process and equipment deviation investigations

• Provide process engineering design input for bioreactor and primary recovery systems

• Perform impact and risk assessments for new processes and unit operations as needed for existing equipment

• Ensure processing equipment remains compliant with PR&D Quality System requirements, applicable engineering standards, and cGMP requirements

• Provide engineering and equipment input for tech transfer of new processes from development

• Active process monitoring of ongoing campaigns

• Provide process engineering support for the commissioning and qualification of new equipment or re-qualification activities as needed

• Active engagement and interaction with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing

Basic Requirements:

• BS in chemical engineering, biological engineering, related discipline and 7+ years relevant experience OR MS in chemical engineering, biological engineering, related discipline and 5+ years relevant experience

• Experience in production unit operations supporting cell culture and/or fermentation operations

Additional Skills/Preferences:

• Experience in GMP biopharmaceutical production environments

• DeltaV and OSI-PI proficiency

• Experience reading Piping and Instrumentation Diagrams

• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability.

• Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management.

• Problem solving skills

• Understanding of process control systems

Additional Information:

• Position located in Indianapolis, IN at the Lilly Technology Center North

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