Process Engineer Dry External Manufacturing

The Dry Products Process Engineer provides technical leadership and support in conjunction with Dry Products External Manufacturing contract manufacturer personnel for the reliable supply and commercialization of medicines with safety first and quality always. The role develops and sustains process knowledge, provides process and equipment support, drives continuous improvement, and ensures HSE/PSM compliance at contract manufacturing sites. Key Objectives/Deliverables: Utilize past experiences with unit operation control to provide insight and feedback to members of the CM Joint Process Team (JPT).Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions with CM members of the JPT.Support and peer review root cause analysis around FUME and operational incidents.Identify process knowledge gaps that impact equipment and process capability; develop or support the capture of key process knowledge.Identify systemic issues affecting production and reliable supply from CMs; lead or participate in root cause analysis and countermeasure development.Support development and technical analysis for ongoing continuous improvement activities; review and identify cost reduction opportunities.Create methodology to ensure visibility of the ongoing state of qualification of key FUME systems at CMs.Serve as liaison for Dry-EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) oversight at contract manufacturing sites.Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of Dry-EM contract manufacturing sites (FRAP, Red Book, contract manufacturing standards, engineering standards, and Quality policies). Basic

BE/BTech/M.E/M.Tech in Mechanical or Chemical Engineering, or any another engineering disciplineRelevant manufacturing experience in Dry Product manufacturing of Tablets/Capsules of at least 8 yearsTechnical knowledge of Dry manufacturing equipment and unit operations.Demonstrated ability to apply engineering principles to process understanding, problem solving, and process improvement.Demonstrated ability to function in a team environment as a technical leader and as a member of teams.Demonstrated ability to manage and prioritize competing priorities and to communicate verbally and in writing to various audiences.Thorough understanding of cGMPs and drug product manufacturing.Experience in Statistical Process Control (SPC) and Six .