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 39,000 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.
The Process Engineering Responsible Engineer provides technical leadership and expertise for production operations in the areas of: Coaching and Mentoring Front Line Process Engineers, Developing and Sustaining Process Knowledge, Process & Equipment Support, Process Optimization & Continuous Improvement, Equipment Capability & Asset Management, and Adherence to Business Systems.
Coach and Mentor Front-Line Process Engineers
Coach and mentor front-line process engineers in aspects of fundamental engineering support including process understanding (both theoretical and practical), problem solving, project management, and engineering design.
Relate experiences with troubleshooting bioprocess equipment within area of support, ie Bioreactors, chromatography, TFF, CIP, etc
Ensure product change over requirements are being met, Critical Process Parameter assessment, Extractables Leachables assessment, GMP Critical Operational Data Instrumentation
Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions. Ensure operational control strategies are appropriate and implemented.
Support and peer review root cause analysis around equipment and operational events, support complex change controls, investigations.
Present and attend various Governance teams as required for technical initiatives.
Promote and peer review documentation of learning points, technical studies, and event investigations.
Develop and Sustain Process Knowledge
Identify process knowledge gaps that impact equipment and process capability.
Enable the development and/or maintenance of process knowledge infrastructure such as key models, report history, lab models, and literature
Utilize optimization resources and tools for process analysis and process improvement studies.
Develop and support technical training of operations team members.
Support development, review, and tracking of key process engineering metrics.
Process Optimization & Continuous Improvement
Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, new product introduction, capacity development, GMP remediation, and safety risk mitigation.
Review and identify cost reduction opportunities as well as process capacities and bottlenecks and assist in prioritization of opportunities with respect to overall business objectives.
Apply statistical thinking and methods to understand process variability and capability and drive improvements.
Perform and promote optimization of unit operation cycle time, loading, and yield performance.
Collaborate with key support groups around the development of process knowledge and a common process improvement agenda.
Equipment Capability and Asset Management
Provide technical oversight of Asset Qualification Management for Direct Impact systems to ensure constant state of qualification.
Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure that equipment/systems are appropriate for the intended purpose.
Provide guidance in development of test plans for Commissioning and Qualification packages and associated critical components.
Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance.
Support scope development for capital projects targeted at both short and long term needs and act as user representative in some cases.
Review and approve documentation/decisions requiring "Responsible Engineer" level of authority.
Accomplish all job functions with adherence to company policies, in a cGMP manner, safely and ethically.
Bachelor of Science, Chemical, Mechanical Engineering or related engineering discipline
A minimum of 8 years industrial experience in a cGMP environment
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Knowledge of / experience with several biopharmaceutical processes and equipment, such as bioreactors, centrifuges, TFF and chromatography systems, media/buffer prep and CIP/SIP.
Strong leadership skills
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.
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