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Sterility Assurance Associate

The Sterility Assurance Associate will join an on-field cross-functional team as Sterility Assurance representative, ensuring that the production process of sterile injectable pharmaceuticals is executed with the necessary robustness and appropriate sterility assurance in conformity to current procedures, cGMP and Eli Lilly standards. He/she will also manage Sterility Assurance issues as primary contact point in the Team and will prepare, review and share Sterility Assurance metrics in leadership meetings, as well as draft and review qualification and strategy documents. He/She will report directly to the Sterility Assurance Team Leader and will be part of TSMS (Technical Service Manufacturing Science) organization.

Main responsibilities of the role:

  • Follow the daily production activities to ensure that the contamination control strategy is applied, and is accountable for the escalation process in case of issues emerging in 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 departments to improve and sponsor the Sterility Assurance culture;
  • Participate in personnel training for aseptic gowning qualification and collaborate in writing procedures and training courses;
  • Evaluate Environmental Monitoring data in collaboration with EM team;
  • With regard to Sterility Assurance, he/she supports the preparation to Regulatory Inspections and Site inspection program;
  • Participate to investigations related to production areas, in cooperation with other functions and the cross-functional Team;
  • Write and/or review documents as EMPQ, PQE, PERV, APS, in relation to aspects of Sterility Assurance;
  • Investigate the impact of changes in relation to aspects of Sterility Assurance;
  • Collaborate in Network activities and initiatives;

Basic Requirements:

  • Scientific Master’s Degree (Pharma, Biotech and Microbiology will be preferred);
  • Good knowledge of English (minimum B2 level);
  • Knowledge of aseptic processes, Sterility Assurance concepts and microbiological notions;
  • Knowledge of current GMP's, and pharmaceutical legislation and regulatory requirements;

Additional Skills/Preferences:

  • 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 products and previous experience in Quality or Sterility Assurance role;
  • Good problem solving skills, decision-making attitude;
  • Communication and influencing skills with the ability to interact effectively with all levels of the organization;
  • Good team working/partnership skills to working a cross-functional organization;
  • Fluent understanding of Sterility Assurance guidelines (es. Annex 1);


Degrees of interest: Scientific Master’s Degree