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 35,000 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.
Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.
Position Brand Description:
This position is responsible for providing engineering support of manufacturing equipment and operations. This position will interact various team members on Process Team, including technical services/manufacturing sciences, 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.
Manage for Results /Strategic Planning:
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.
- 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.
- Active participation in Process Teams to verify that process is in control; use of first principles, RCA or other tools to reach conclusion and recommendations for remediation of any problems or deviations.
- Supports Process Team by responding to questions, sharing process knowledge, and troubleshooting issues as they occur.
- Respond to operations needs and handles standard and non-standard requests.
- Lead equipment related investigation and resolutions.
- Provide process related input to process team for deviations and observations.
- Make decisions that impact own priorities and allocation of time to meet deadlines.
- Execute, or assist, in process related change controls. Own equipment Standard Operating Procedures (SOP), related CAPAs and changes.
- Perform safety assessments as required for change controls and any project related activity. Effect incremental improvement.
- Perform key responsibilities of discipline other than Process Engineering; Automation – support measurement and control systems, Maintenance – ensuring an asset’s functionality is maintained.
- Creates or modifies SOPs for Engineering procedures as required.
- Own manufacturing SOP’s and participates in the reviews and approvals of 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.
- 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.
- Bachelor of Science (Chemical, Mechanical, Biomedical Engineering or related engineering discipline) with 2-10 years industrial experience in a cGMP environment.
- Knowledge of / experience with several biopharmaceutical processes and equipment, such as bioreactors, centrifuges, TFF and chromatography systems, media/buffer prep and CIP/SIP.
- 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.
- Required to be on call.
- Shift work may apply.
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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.
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.