Lilly Sterility Assurance Associate in Sesto Fiorentino, Italy
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 35,000 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.
Will be part of the Process Team as (cross-functional team on field) as Sterility Assurance representative 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 procedure, cGMP and Eli Lilly standards. Manage Sterility Assurance issues as Sterility Assurance primary contact in the Process Team also prepared, review and share the Sterility Assurance metrics in the leadership meeting. Prepared and review qualification and strategy documents. The person that will be cover this role, will be report directly to the Sterility Assurance Team Leader and will be part of TSMS (Technical Service Manufacturing Science) organization.
You will specifically support on the following activities:
Responsibilities may be slightly different based on seniority and increase complexity in the process.
He/she follow the daily production activities to assure that the contamination control strategy is applied, and he/she is accountable for the escalation process in case of any issue into the production area.
Implement Media fill, filtration validation, EMPQ, sanitization, sterilization, depyrogenation, gowning, sanitization agents validation, CCI strategy on field and involvement in regular oversight activities in production department to improve and sponsor the Sterility Assurance culture.
Participates in the personnel training for aseptic gowning qualification and collaborates in the writing of procedure and training course.
Evaluation of Environmental Monitoring data in the collaboration with EM team.
He/she is responsible 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.
Write and/or review documents as EMPQ, PQE, PERV, APS, etc in relation to aspect of sterility assurance.
Investigates the impact of changes in relation to aspects of Sterility Assurance.
Collaborate and participate to Network activities and initiatives.
Master’s Degree (Scientific) Pharma, Biotech and Microbiology Field will be preferred.
Good knowledge of English (at least B2 CEFR).
Knowledge of aseptic processes, Sterility Assurance concepts and microbiological notions.
Knowledge of current GMP's, and pharmaceutical legislation and regulatory requirements.
Understanding of quality principles and their applications in pharmaceutical manufacturing.
Deep knowledge of microbiological aspects applied to pharmaceutical companies.
Previous experience in GMP manufacturing of sterile medicinal product and previous experience in Quality or Sterility Assurance role.
Good problem solving skills, decision-making attitude and stress management.
Communication and influencing skills with the ability to interact effectively with all level of the organization.
Good team working/ partnership skills to working a cross-functional organization.
Pragmatic approach and compliance mindset.
Fluent understanding of Sterility Assurance guidelines (es. Annex 1).
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 ( LillyRecruitingCompliance@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.
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!