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.
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 cGMP 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:
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
