Principal Scientist, TSMS Cleaning Validation - ADN RAMP Team

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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description: 

The Lilly API/Dry Product Network is rapidly expanding to meet the demand for new products, and several new greenfield sites are under construction and will be starting up in the coming years. The new sites are staffed based on full-scale, steady state production, however additional surge capacity is needed to support the site start-up and help quickly ramp to full capacity rates.  

The ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly’s vision of serving more patients.  

Success in this challenging role will require supporting the sites through startup, through direct technical execution, coaching next employees, and strong collaboration – and development of the local technical and operational teams to be ready for full operation. 

The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director.   

Key Objectives/Deliverables: 

Responsible for the development, implementation and establishing ongoing monitoring of the Cleaning Program for new site facilities including but not limited to: 

• Support new site TSMS cleaning teams on developing Cleaning Validation Master Plan for the facility, using expertise and benchmarking from other sites. 

• Develop a standard and clear procedure for conducting a Cleaning Assessment and train relevant personnel on how to implement and maintain. 

• Standardize Cleaning procedures and operating instructions – ensure critical information is present and critical operating parameters for effective cleaning are integrated into electronic tickets. 

• Standardize pre-start sa