Program Coordinator, Aseptic Process Simulation

About the Job

The Program Coordinator for the Aseptic Process Simulation Program (APS) organizes all aspects of aseptic process simulation activities at the 503B outsourcing facility. The coordinator coordinates the departments responsible for the design, execution, and implementation of media‑fill protocols that qualify aseptic operations across multiple sterile areas and production lines. Working with the Validation department manager and the Manufacturing Quality (MQ) team, the Program Coordinator ensures that all APS events are scientifically sound, compliant with FDA 503B guidance, cGMP guidelines for sterile manufacturing, and other relevant rules and guidelines, and that they accurately simulate routine production practices.

• Coordinate the aseptic process simulation program across Validation, Production and Quality Assurance to ensure compliance, efficiency, and alignment with regulatory expectations for 503B outsourcing facilities.
• Develop and approve media‑fill protocols that accurately model production operations, including interventions, personnel activities, and equipment configurations for each aseptic line.
• Oversee the planning and real‑time execution of approximately 2–4 media fills per month, ensuring adherence to validated procedures, aseptic technique, and contamination control principles.
• Coordinate cross‑functional support from manufacturing, quality control, and facilities.
• Ensure timely documentation, investigation, and closure of any protocol deviations, failures, or environmental anomalies identified during media fill events.
• Support the Aseptic Training team by analyzing performance trends to identify opportunities for improving aseptic practices, reducing risk, and optimizing fill efficiency.
• Work with the Aseptic Training team to ensure all APS participants are appropriately trained and qualified in aseptic technique, gowning, and simulation protocols.

• Bachelor's degree in Microbiology, Life Sciences, Engineering, or a related discipline (advanced degree preferred).
• Minimum 5 years in sterile pharmaceutical manufacturing or 503B compounding.
• Understanding of FDA 503B guidance, cGMP (21 CFR Parts 210/211), and Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing current Good Manufacturing Practice.
• Leadership and project management capabilities.
• Communication, problem‑solving, and decision‑making skills.