Principal Engineer, IDAP TS/MS Product (R3 - R5)

Eli Lilly and Company seeks a Principal Engineer, IDAP TS/MS Product (R3 - R5) to drive the technical agenda for the Indianapolis Device and Packaging (IDAP) site. Provide technical support on non-routine investigations, including on quality and stability. Prepare technical documents including annual product reviews, change controls, regulatory submissions, deviations, validations, and procedures. Monitor process control and capability. Lead technical projects to improve process control and productivity. Drive technical consistency across process teams. Serve as interface with upstream suppliers and global device and drug product networks. #LI-DNI Position requires a Master's degree in Pharmacy, Biotechnology, Pharmaceutical Engineering, or a related field, and 2 years of experience with pharmaceutical engineering. Experience must include a minimum of: 1 year of experience with current good manufacturing processes (cGMPs); 1 year of experience with cleaning validation, root cause investigation, and manufacturing statistics; 1 year of experience with coordination of cross-functional teams; 1 year of experience with validations for site transfers, new equipment, process changes, and solid oral dosage forms; and 1 year of experience with design and execution of experimental trials in compliance with SOPs, FDA/ICH guidelines, DEA regulations, and safety requirements for validation activities, and investigations. Part-time telecommuting permitted. Up to 20% domestic and international travel required. #LI-DNI Job location: Indianapolis, IN. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-91515 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285.