Aseptic Process Simulation Program Lead

Fagron Tech; Wichita (KS); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

401(k) plan with company matching

Medical insurance

Vision and dental

Health Savings Account (HSA)

Paid time off

Job summary

Fagron is seeking a Program Coordinator for the Aseptic Process Simulation Program to organize all APS activities at the 503B outsourcing facility. This role coordinates design, execution, and implementation of media-fill protocols across sterile areas and production lines.

You will work with Validation, Production and MQ teams to ensure compliance with FDA 503B guidance and cGMP standards, maintaining thorough documentation and timely final reports.

Qualifications

• Bachelor’s degree in Microbiology, Life Sciences, Engineering, or 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.
• Proficiency in electronic quality systems, deviation management, and protocol/report authorship.
• Quality-driven and detail-oriented mindset
• Ability to lead and influence cross-functional teams
• Strong accountability and regulatory awareness
• Commitment to data integrity, compliance, and continuous improvement

Responsibilities

• Coordinate the site’s aseptic process simulation program, working with Validation, Production and Quality Assurance to ensure it remains compliant, efficient, and aligned 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 with 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 involved in executing the APS are appropriately trained and qualified in aseptic technique, gowning, and simulation protocols.

Skills

Leadership

Project management

Communication

Problem-solving

Regulatory awareness

Data integrity

Cross-functional collaboration

Gowning and aseptic technique

Analytical thinking

Education

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

Tools

Electronic quality systems

Deviation management

Protocol/report authorship

Job description

Fagron is seeking a Program Coordinator for the Aseptic Process Simulation Program to organize all APS activities at the 503B outsourcing facility. This role coordinates design, execution, and implementation of media-fill protocols across sterile areas and production lines.

You will work with Validation, Production and MQ teams to ensure compliance with FDA 503B guidance and cGMP standards, maintaining thorough documentation and timely final reports.