Advisor - Equipment Cleaning - TSMS - Lebanon API Manufacturing

Overview

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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

The Cleaning Advisor will play a critical role in setting site-wide strategy and supporting cleaning validation activities for API manufacturing at Lilly Lebanon API plant. This position is responsible for managing the cleaning program for process equipment and ancillary components at the Lebanon manufacturing facility. The Cleaning Advisor will work with cleaning reps for developing and executing product-specific cleaning validation documentation and strategies, ensuring compliance with global standards, and fostering collaboration across Lilly manufacturing operations.

This position will interact with Engineering, Manufacturing, Quality Assurance, Quality Control, Validation, Development, and Regulatory departments. Interaction may be required with other Lilly site/contract producers of Lilly products.

This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions. The successful candidate should have a proven track record of driving technical and manufacturing agendas in equipment cleaning.

• Maintain existing strategies and supporting documentation relating to the following:
  • Cleaning equipment and cleaning cycles
  • Cleaning validation, verification, re-qualification, and re-validation
  • Cleaning limits
  • New product introduction and cleaning challenge determination
  • Cleaning procedures and associated work instructions
• Author new strategies and supporting documentation to meet changing business needs.
• Work closely with technical leadership to actively manage cleaning development and cleaning verification/validation activities according to schedule.
• Oversee execution of cleaning validation protocols and ensure alignment with approved strategies. Provide support to the process teams for cleaning activities ensuring all aspects of the flow are coordinated appropriately. Attend and lead (if required) process team meetings.
• Provide technical support and advice on cleaning deviations/events as required. Oversee trending of data and events across equipment trains and products to drive improvements.
• Provide technical review of changes to determine potential impact to the cleaning program and cleaning validation.
• Collaborate globally across Lilly sites to promote shared learning and continuous improvement in cleaning validation practices.
• Remain current on new industry and regulatory trends relating to cleaning equipment and cleaning regimes.
• Represent the cleaning program including validation status and results to regulatory agencies in informational meetings and routine inspections.
• Apply science- and risk-based approaches to enhance the robustness, efficiency, and compliance of cleaning processes.
• Develop and deliver training and educational materials on cleaning validation and related topics across LP1 manufacturing operations.
• Ensure cleaning validation activities are aligned with governing standards set by regulatory agencies and internal Lilly…