Expert Technician - Production

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Position Overview: The Manufacturing team handles the aseptic production of radiopharmaceutical drug products and radioisotopes at our GMP facility, working within established batch records and strict cGMP requirements. Because these materials have short half-lives, the team operates under tight timelines and coordinates closely with Quality Control, Quality Assurance, and Engineering to keep production running and to release product on schedule. It is highly regulated work where product quality, radiation safety, and on-time delivery all have to be managed at once. The Expert Technician, Manufacturing is a mid-senior individual-contributor role on that team. Reporting to the Supervisor/Manager of Manufacturing, this person runs aseptic production, but strong technical documentation skill is central to the role. They investigate and resolve deviations, non-conformances, and OOS events, and they author and maintain the GMP records: deviations, CAPAs, change controls, investigations, and SOP revisions. The role pairs hands-on aseptic production with the technical writing rigor that keeps the facility operational and inspection-ready. Responsibilities: Reporting to the Supervisor/Manager of Manufacturing, the Expert Technician, Production will have responsibility for: Aseptic production of radiopharmaceutical drug product and radioisotopes in accordance with established manufacturing batch records. Support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products and radioisotope products. Investigate, resolve, and mitigate deviations, non-conformances, and OOS (Out of Specification) events associated with product manufacturing at the GMP facility. Monitor production-related equipment to ensure proper function and compliance with the established calibration / PM equipment schedule. Continuous process improvement of existing manufacturing methods via Current Good Manufacturing Practices (cGMP). Maintain cross-functional production communications and operational planning tools to support on-time task execution. Produce radioisotopes and drug products following cGMP guidelines and resolve all production-related quality events in a timely manner. Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of drug product and radioisotopes. Participate in technical transfer and process validation activities in collaboration with other departments. Safely work with radioactive materials following ALARA principles and NRC guidelines. Utilize and monitor all manufacturing-related equipment. Conduct and appropriately document aseptic production of radiopharmaceutical drug product and radioisotopes via strict adherence to manufacturing batch records and affiliated SOPs. Safely handle and participate in the transfer of radioactive materials throughout the facility. Monitor manufacturing equipment to ensure performance and safety standards are met. Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use. Provide verbal and written reports to supervisors in a clear and concise manner. Maintain accurate and complete lab data notebooks as per cGLP and/or cGMP, as appropriate. Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements. Embody and promote a quality culture and due diligence approach as part of all activities. Author, review, and maintain GMP documentation and technical writing deliverables, including deviations, non-conformances, CAPAs (Corrective and Preventive Actions), change controls (CCs), investigations, and SOP revisions, ensuring clear, accurate, and audit-ready records. Basic Qualifications: Earned c ollege/Associate level diploma/degree in a related scientific field of study 3+ years of relevant experience in a manufacturing environment or similar field of work. Aseptic and/or cGMP manufacturing experience is preferred. Demonstrated GMP documentation exposure and technical writing ability, including hands-on experience authoring or supporting deviations, CAPAs, change controls (CCs), investigations, and other quality records. Ability to work in a fast-paced environment with shifting priorities, while working with a sense of urgency. Strong attention to detail and ability to follow repetitive processes without error. Maintain clear, consistent, and constant verbal communication with one or more team members during performance of duties. Full range of motion and ability to use both hands mandated by machinery. High degree of manual dexterity. Regular lifting of 10 lb weights, occasional lifting of up to 50 lbs. Excellent organizational and interpersonal skills with the desire and ability to work in a team centered environment. Availability to work variable shifts, including evenings, weekends, and holidays, as required to support manufacturing operations. Additional Preferences: Earned Bachelor's d egree in a related scientific field of study Experience working with radiopharmaceuticals is an asset. Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique. Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel). Working knowledge of production scheduling, document control workflows, and operational tracking tools. Demonstrated initiative in identifying and implementing process improvements and innovation ideas. Support production documentation and radiation-safety activities (ledgers, swipe testing, area monitoring) across manufacturing and research spaces, while mentoring fellow technicians on procedures, documentation, and equipment. Contribute to continuous improvement, innovation, and new-product readiness initiatives. 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender ide