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 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.
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.
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at firstname.lastname@example.org.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-21901.