Scientist - Sterility Assurance - Technical Services/Manufacturing Science

Scientist - Sterility Assurance - Technical Services/Manufacturing Science

Eli Lilly Benelux

Alzey, Germany

Responsibilities:

The Sterility Assurance Scientist is a technical role that assists in development and implementation of the site’s sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role is also expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to sterility assurance.

Key Objectives/Deliverables:

• (Associate/Senior) Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level;
• Lead or provide technical oversight for Provide technical support for activities related to sterility assurance programs including but not limited to:
  • Airflow Pattern Testing;
  • Environmental Monitoring Performance Qualifications;
  • Aseptic Process Simulations;
  • Cleaning, Sanitization, and Disinfection;
  • Gowning within GMP Classified Areas;
  • Aseptic Processing Techniques;
  • Contamination Control.
• Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established;
• (Senior) Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established;
• (Senior) 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;
• (Senior) Lead/assist with support and/or provide technical expertise for the facility’s cleanroom gowning and aseptic technique strategy/program;
• (Principal) Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification;
• (Principal) Lead/provide technical oversight for one or both the Environmental Monitoring (EM) or Aseptic Process Simulation (APS) program:
  • (EM) Authoring EM Performance Qualifications (EM PQ) and overseeing the execution;
  • (EM) Evaluating EM data and authoring EM Trend Reports;
  • (EM) Assist with identifying facility environmental isolates and how to create and maintain environmental isolate cultures;
  • (APS) Authoring APS protocols and overseeing the execution;
  • (APS) Evaluating the APS data, including personnel qualifications, and authoring APS reports;
  • (APS) 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.

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;
• (Senior) 2+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept);
• (Principal) 5+ 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.