At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities.
Position Summary:
The individual in this role will be responsible for upstream process equipment supporting our 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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