Engineer-TS/MS-Product/Process

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. **Position Description:** Serve as TS/MS Product/Process representative of manufacturing/packaging process teams to provide technical support: * Responsible for ensuring for its area of expertise that complex process issues are addressed in a structured and resolved manner and, if necessary, scaled to the Secondary Loop. * Supports product process and sterile manufacturing process related studies and validation activities due to change or project. **Key Objectives/Deliverables:** Product Process related： * Overseeing process capability (process in control and capable) and yield variables, including: Assisting the Process Team with identifying sources of variation (i.e. common or special cause variability) and recommending appropriate improvements; Owning the process mass balance and the potential sources of product losses including waste. * Understand the Operational Control Strategies and own the process /product related portions of the Control Strategy including how the process parameters and other input variables (e.g. CPP and CIPC) can potentially impact the Critical Quality Attributes (CQA),as well as the historic and potential failure modes for the process and their associated countermeasures (e.g. iMCS). * Know the product/process control factors, the analytical control strategy and the development and validation history. * Ensure there is an accurate Process Flow Document (PFD) that describes the process, analytical me