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Principal Process Engineer

1 month ago

Indianapolis, United States Eli Lilly Full time

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.This position is part of the Bioprocess Development (BR&D) organization. The individual in this role will be responsible for upstream process equipment supporting a Clinical Trials Manufacturing Facility. They will interface with development and operations for tech transfer activities and serve as the main contact for troubleshooting any equipment issues. Responsibilities:The bioprocess pilot plant contains both stainless steel and single-use equipment to support several different clinical trial manufacturing processes. The individual in this role provides engineering support to the maintenance and operations groups as needed to maintain production of Bulk API for development and clinical trial purposes. The individual in this role has the following responsibilities:Provide engineering support in the pilot plant, e.g., troubleshoot process and equipment issues, lead process equipment change controls, and lead process and equipment deviation investigationsProvide process engineering design input for bioreactor and primary recovery systemsPerform impact and risk assessments for new processes and unit operations as needed for existing equipmentEnsure processing equipment remains compliant with PR&D Quality System requirements, applicable engineering standards, and cGMP requirementsProvide engineering and equipment input for tech transfer of new processes from developmentActive process monitoring of ongoing campaignsProvide process engineering support for the commissioning and qualification of new equipment or re-qualification activities as neededActive engagement and interaction with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and ManufacturingBasic Requirements:BS in chemical engineering, biological engineering, related discipline and 7+ years relevant experience OR MS in chemical engineering, biological engineering, related discipline and 5+ years relevant experienceExperience in production unit operations supporting cell culture and/or fermentation operationsAdditional Skills/Preferences:Experience in GMP biopharmaceutical production environmentsDeltaV and OSI-PI proficiencyExperience reading Piping and Instrumentation DiagramsAbility to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability.Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management.Problem solving skillsUnderstanding of process control systemsAdditional Information:Position located in Indianapolis, IN at the Lilly Technology Center NorthEli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.#WeAreLilly