Sterility Assurance Specialist

1 week ago

Pleasant Prairie, Wisconsin, United States Eli Lilly Full time
Job Title: Sterility Assurance Scientist

We are seeking a highly skilled Sterility Assurance Scientist to join our team at Eli Lilly. As a key member of our Parenteral Process Team, you will be responsible for developing and implementing sterility assurance programs to ensure the quality and safety of our pharmaceutical products.

Responsibilities:
  • Develop and implement sterility assurance programs to ensure the quality and safety of our pharmaceutical products.
  • Provide technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies.
  • 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.
  • Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
  • Lead/assist with support and/or provide technical expertise for developing the site's contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies.
  • Lead/assist with support and/or provide technical expertise for the facility's cleanroom gowning and aseptic technique strategy/program.
  • Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification.
  • Lead/provide technical oversight for one or both the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program.
  • Authoring EM Performance Qualifications (EM PQ) and overseeing the execution.
  • Evaluating EM data and authoring EM Trend Reports.
  • Assist with identifying facility environmental isolates and how to create and maintain environmental isolate cultures.
  • Authoring APS protocols and overseeing the execution.
  • Evaluating the APS data, including personnel qualifications, and authoring APS reports.
  • Assist with tracking and tending APS to ensure all regulatory requirements and Global Quality Standards are met for each manufacturing line/process.
  • 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.
  • Lead or provide technical support for root cause investigations associated with sterility assurance programs.
  • Participate and/or provide technical sterility assurance support during internal and external audits.
  • Create, execute, review, and/or approve technical documents and change controls related to sterility assurance programs.
  • Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives.
Requirements:
  • 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).
Preferred Skills:
  • 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.
  • Ability to wear appropriate PPE and other safety-related equipment or considerations in manufacturing, warehouse, or laboratory areas.
  • Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.

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