Sterility Assurance Associate

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.

Role Summary

Will be part of the Process Team (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. Will manage Sterility Assurance issues as Sterility Assurance primary contact in the Process Team. Prepare, review and share the Sterility Assurance metrics in the leadership meeting. Prepare and review qualification and strategy documents. Will report directly to the Sterility Assurance Floor Coordinator 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 APS, 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 QA/QC 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, ASST 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.

Basic Requirements:

- Master's Degree (Scientific) Pharma, Biotech and Microbiology Field (preferred).
- Good knowledge of English (at least B2 CEFR).
- Previous experience in GMP manufacturing of sterile medicinal product, previous experience in Quality or Sterility Assurance role preferred.
- Knowledge of aseptic processes, Sterility Assurance concepts and microbiological notions.
- Deep knowledge of microbiological aspects applied to pharmaceutical companies.
- Knowledge of current GMP's, and pharmaceutical legislation and regulatory requirements.

Additional Skills/Preferences:

- 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).

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.

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