Lead Parenteral Engineer DP External Manufacturing

Overview 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. The Drug Product External Manufacturing (DPEM) organization plays a critical role in delivering Lilly medicines through a global network of trusted Contract Manufacturers (CMs). DPEM ensures: Seamless commercialization and launch of new drug products Smooth technology transfers of approved products across CMOs Reliable, safe, and timely delivery of high-quality medicines by our external partners Within this framework, the DPEM Engineering Group provides expert engineering support across diverse technologies and geographies. Our mission is to enhance the reliability, efficiency, and quality of external manufacturing through a team of highly skilled and engaged professionals. At the heart of this mission is the DPEM Lead Parenteral Engineer, who is a key technical leader supporting parenteral product operations at CM sites worldwide. Role Overview: The Lead Parenteral Engineer DPEM delivers technical excellence across all parenteral platforms and assets at CMOs. This includes: Partnering with the Commercialization Team to launch new parenteral products Supporting technology transfers for new, launching, or reallocated products Providing engineering leadership within the Joint Process Team (JPT) to ensure uninterrupted market supply The role focuses on hands-on technical support, troubleshooting, deviation resolution, process monitoring, continuous improvement, and equipment qualification, while ensuring compliance with regulatory and safety standards. Key Responsibilities Commercialization Support Participate in commercialization teams to identify and deliver technical knowledge for aseptic operations, demo batches, and documentation. Build deep process knowledge to enable future tech transfers. Technology Transfer Collaborate with project managers and cross-functional teams onboarding new or existing products at CMOs. Serve as a technical mentor in Aseptic Processing (such as line setup, interventions/operations, etc.) and Parenteral Technologies (material resistance, compatibility, decontamination, cleaning, sterilization, design matters, etc.). Support engineering, demo, and PV batch execution. Contribute to change controls, risk assessments, and technical documentation (i.e., change controls, Tech Transfer Plans, PFMEA, risk/gap assessments). Operational Support with Joint Process Team Review and support CMOs on Aseptic operation (line setup, aseptic interventions or operations, etc.) and Parenteral Technologies (filtering testing, filling profile, etc.). Support technical evaluations, root cause investigations, and process improvements. Help on deviation evaluation and management from a technical point of view. Drive change evaluation and implementation, replicate best practices across platforms, and coach CMOs on engineering, maintenance, and lifecycle management. Interact with Lilly central functions on change management, safety assessments, process improvement, etc., leveraging variability control and data analysis. Actively participate in network meetings and in the continuous improvement project Drive the EOM (equipment supplier) to continuous improvement, obsolescence, and replication of best practices across similar platforms. Influence CMOs on compliance culture and HSE standards Key Collaborations DPEM and Lilly External Manufacturing teams Contract Manufacturing organizations Lilly Manufacturing Network functions (e.g., M&Q, GPP, ETC Qualifications Basic: Bachelor’s degree in engineering. 3 years in parenteral manufacturing technologies (Filling equipment, Isolator, RABs, Inspection systems, Component preparation, Formulation, etc.). 3 years in cGMP manufacturing or support. Fluent in English. Preferred: Scrupulous attention to quality, data integrity, and HSE aspects Learning agility, curiosity, a can-do attitude, and proven ability to manage multiple tasks and complex projects concurrently. Strong communication skills, both written and verbal, with strong interpersonal capabilities. Highly organized, collaborative team player with a proactive and adaptable mindset. Soft relationship skills and teamwork Strong cross-functional collaboration, problem-solving skills, result-driven attitude, and continuous improvement orientation. Proven ability to manage multiple tasks and complex projects concurrently. Experience working across functional and geographic boundaries Influence, autonomy, and leadership attitude Travel Requirement Up to 30-40% travel to support regional CMOs (OUS for OUS and US for US) This position requires working on-site and includes 4 days of remote work per month. What we offer Step into a role where your expertise is recognized, appreciated, and rewarded. As a member of our team, you can expect: Competitive Salary : We offer a competitive base salary supplemented by an annual variable component based on achieving objectives. Relocation Package: You will be eligible for a relocation package based on your location. Comprehensive Benefits : Enjoy a well-rounded welfare package, including an extensive insurance plan. Annual Salary Review : We recognize and reward your continued effort with an annual salary review, providing opportunities for advancement based on your performance. As part of our commitment to your future, you may also be eligible to receive a stock option package, aligning your success with the company's growth. 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 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 identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. WeAreLilly J-18808-Ljbffr

Location: Sesto Fiorentino, Toscana, IT

Posted Date: 10/8/2025