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Sterility Assurance Specialist

2 weeks ago


Concord NC, United States Eli Lilly and Company Full time

Company Overview

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. Our mission is to unite caring with discovery to make life better for people around the world.

We are committed to improving the understanding and management of disease, as well as bringing life-changing medicines to those who need them.

Job Description

The Sterility Assurance Scientist is a technical role that assists in the development and implementation of sterility assurance programs at our manufacturing facilities.

This position provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies.

Key Responsibilities

  • Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.
  • Lead or provide technical oversight for activities related to sterility assurance programs, including airflow pattern testing, environmental monitoring performance qualifications, aseptic process simulations, cleaning, sanitization, and disinfection.
  • Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
  • Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination.
  • Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements.
  • Participate and/or provide technical support during internal and external audits.

Basic Qualifications

  • Bachelor's or Master's Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
  • Demonstrated understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing.
  • 2+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept).

Additional Skills/Preferences

  • Possess strong interpersonal skills to work cross-functionally within a team.
  • Possess strong self-management and organizational skills.
  • Possess strong oral and written communication skills for communicating to colleagues, management, and other departments.
  • Experience with data analysis and trending.