Aseptic Process Simulation Program Lead

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

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.