Scientist - TSMS Sterility Assurance

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: Will be responsible for Sterility Assurance technical activities associated with the TSMS group and reference as Subject Matter Expert for Sterility Assurance technical aspects. Ensuring that the production process of the sterile injectable pharmaceuticals is executed with the necessary robustness and the appropriate sterility assurance in conformity to the current regulations and procedure (Annex 1, Lilly Global standard, etc). A person in this position has a strong Manufacturing background and is expected to plan and define the strategy on Sterility Assurance topics and is responsible and technical referent for Sterility Assurance technical documents (APS, Environmental monitoring, CCI, etc.). Collaborates with the Technical Team/Flow Team/Process teams for STA impact assessments and will participate actively in Network discussions and ensures alignment with this. The person that will cover this role will report directly to the Associate Director – TSMS Sterility Assurance and will be part of TSMS (Technical Service Manufacturing Science) organization and will Participate to the technical development of junior Sterility assurance. Responsibilities: Collaborates with the Technical Team and therefore has the responsibility of performing the Sterility Assurance technical impact assessment and then identifying Sterility Assurance strategies in relation to the project agenda; guides the definition of VPHP Decontamination, Sterilization, Depyrogenation, Cleaning validation (micro aspects) HVAC & Clean Utilities qualification strategies and involvement in regular oversight activities in production department to improve and sponsor the Sterility Assurance culture. is Leading Investigator in case of complex and / or long deviations or in case of important technical problems, coordinating the troubleshooting / RCA; is Author / Reviewer of documents such as Assessment, technical procedure, and technical documentation is a member and representative of the site in specific meetings and discussions of global networks and collaborates to the related activities and initiatives; He/she is responsible and point of contact/SME to perform the Sterility Assurance support the preparation and ensure the readiness to any Regulatory inspection; in addition to that he/she supports the site inspection program. He/she participates to any investigation correlated to the production areas, in cooperation with the other functions of the production areas and the Process Team. Basic Requirements: Master’s Degree (Scientific) in Engineering, chemistry, biology or equivalent scientific degree 5 years of experience in more than one GMP Manufacturing function of sterile medicinal product, preferred previous experience in Quality or TSMS/Sterility Assurance role. Good knowledge of English (at least B2 CEFR). Knowledge of aseptic processes, Sterility Assurance concepts and basic microbiological notions. Deep knowledge of engineering/technical aspects related to Isolator/RABS/Sterilization technology applied to pharmaceutical companies. Knowledge of current GMP's, and pharmaceutical legislation and regulatory requirements. Additional Skills/Preferences: Strong self-management and organizational skills. Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization. Demonstrated project management capability. Understanding of quality principles and their applications in pharmaceutical manufacturing. Very good problem-solving skills, decision-making attitude, and stress management. Pragmatic approach and compliance mindset. Strong interpersonal and teamwork skills. Eli 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 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 At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly