Program Coordinator, Aseptic Process Simulation

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 80,000 - 100,000; Full time

Job summary

Fagron Sterile Services US (FSS) in Wichita, Kansas is looking for a Program Coordinator for the Aseptic Process Simulation Program. This vital role involves organizing all aspects of aseptic process activities to ensure compliance with FDA regulations and cGMP guidelines.

The ideal candidate will have a Bachelor's degree in a relevant field and a minimum of 5 years of experience in sterile pharmaceutical manufacturing. The role includes developing protocols, overseeing media fills, and ensuring training and compliance in aseptic techniques.

Qualifications

• 5+ years in sterile pharmaceutical manufacturing or 503B compounding.
• Understanding of FDA 503B guidance and cGMP guidelines.
• Project management capabilities.

Responsibilities

• Coordinate aseptic process simulation for compliance and efficiency.
• Develop media-fill protocols modeling production operations.
• Execute 2–4 media fills per month adhering to validated procedures.
• Coordinate support from manufacturing and quality control.
• Ensure timely documentation and closure of protocol deviations.
• Analyze performance trends to improve aseptic practices.

Skills

Leadership

Communication

Problem-solving

Decision-making

Education

Bachelor's degree in Microbiology, Life Sciences, Engineering, or a related discipline

Job description

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.

Key Responsibilities

• 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.

Basic Qualifications

• 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.