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This position is part of the Bioprocess Development (BR&D) organization. The individual in this role will be responsible for equipment in the K360 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
  
• 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 c GMP requirements
  
• Provide engineering and equipment input for tech transfer of new processes from development
  
• Active process monitoring of ongoing campaigns
  
• Provide process engineering design input for chromatography columns and buffer delivery systems
  
• Provide process engineering support for the commissioning and qualification of new equipment or re-qualification activities as needed
  
• Look for, and implement, opportunities for process optimization and operational excellence
  
• Active engagement and interaction with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing
  

Basic Requirements:

• BS or MS in chemical engineering, biological engineering, related discipline and 2+ years of experience
  
• Experience with large scale column chromatography
  

Additional Skills/Preferences:

• Proficiency in UNICORN Software
  
• Background in GMP biopharmaceutical production environments
  
• 3+ years of experience in biopharmaceutical production unit operations supporting antibody or protein purification operations
  
• Understanding of process control systems
  
• Problem solving skills
  
• Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management.
  
• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability.
  

Additional Information:

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

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