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.
For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
This position is responsible for providing second shift engineering support of manufacturing equipment and operations. This position will interact various team members on Process Team, including TS/MS, manufacturing, validation, and quality assurance, and other Lilly Sites as required. Knowledge of cell culture, purification and support systems, and its associated bioprocessing equipment used in the manufacturing of biotech products is required.
Responsible for supporting clinical and commercial manufacturing operations through representation on Process Teams:
- Respond to and trouble shoot process equipment related issues; provide direct, on-the-floor engineering support of manufacturing processes and maintenance activities. Use historian data and other sources of process data to extract and chart relevant process parameters on a continuous basis. Uses process knowledge to analyze possible solutions to solve a range of problems.
- Ensure regulatory compliance from an equipment and process performance aspect. Understand capability and capacity of unit operations and process.
- Supports Manufacturing by responding to questions, sharing process knowledge, and troubleshooting issues as they occur. Respond to operations needs and handles standard and non-standard requests.
- As required, may support equipment related investigation and resolutions. Provide process related input to process team for deviations and observations.
- own or support for process related change controls, or implementation of CAPAs.
- Reviews and approves operational SOPs and Manufacturing Batch Records, ensuring procedures can be executed as written to ensure practice matches procedure, as it relates to the process equipment and order of operations.
- As required, may provide engineering support to Senior engineers for new product introduction, capital projects, and shutdown related activity.
- Performs all job functions with adherence to company policies, in a cGMP manner, safely and ethically
Basic Requirements:
- Bachelor of Science, Chemical, Mechanical Engineering or related engineering discipline with a minimum of 1 year of relevant experience.
- Experience in fermentation/cell culture and/or protein purification manufacturing.
- Thorough understanding of GMP requirements for a large scale manufacturing facility.
Additional Preferences:
- Strong written and oral communication skills
- Aggressive, curious, and solution driven.
- Self-directed personality, with ability to work independently, self-sufficiently, and proactively in the performance of work duties.
Additional information:
- This is a 2nd shift role: hours are 12pm - 12am with some flexibility, 4 days on/4 days off schedule.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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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.