Cleaning Advisor - Small Molecule

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: Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Main Purpose and Objectives: The Cleaning Advisor is responsible for managing the cleaning program for process equipment and ancillary components at the Lebanon manufacturing facility. This position will interact with Engineering, Manufacturing, Quality Assurance, Quality Control, Validation, Development, and Regulatory departments. Interaction may be required with other Lilly site/contract producers of Lilly products. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions. The successful candidate should have a proven track record of driving technical and manufacturing agendas in small molecule. Key Responsibilities: Maintain existing strategies and supporting documentation relating to the following: Cleaning equipment and cleaning cycles Cleaning validation, verification, re-qualification, and re-validation Cleaning limits Coupon cleanability and product recovery studies New product introduction and cleaning challenge determination Cleaning protocol and report generation Cleaning procedures and associated work instructions Author new strategies and supporting documentation as required to meet the changing business needs. Ensure cleaning validation is current by establishing an annual schedule of cleaning validation, re-qualification, and re-validation activities and tracking progress against the schedule. Complete Periodic Review Reports to ensure cleaning equipment remains in a qualified state. Provide technical support and advice on cleaning deviations/events and assist in root cause analysis and trouble-shooting efforts as required. Provide technical review of changes to determine potential impact to the cleaning program and cleaning validation. Ensure cleaning batch records and reviewed in a timely manner to support batch release. Remain current on new industry and regulatory trends relating to cleaning equipment and cleaning regimes. Represent the cleaning program including validation status and results to regulatory agencies in informational meetings and routine inspections. Provide leadership and technical advice to cleaning engineers. Minimum Requirements: Bachelor's degree in sciences or engineering field (Advanced degree preferred). 5 years of experience in a cGMP large-scale pharmaceutical manufacturing facility. Technical knowledge of cleaning equipment and cleaning regimes. Knowledge of relevant FDA and EU regulations relating to equipment cleaning in small molecule manufacturing. Additional Preferences: Ability to respond quickly and proactively to changing priorities within a limited timeline. Excellent communication skills, both oral and written. Demonstrated leadership skills. Ability to independently master assigned processes and to coordinate activities with internal and external partners. Experience in organic synthesis. Experience in API manufacturing. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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