Aseptic Process Simulation Lead

Fagron; Wichita (KS); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision, dental

Health Savings Account (HSA)

Paid time off

Job summary

Fagron is seeking an Aseptic Process Specialist to organize APS activities at a 503B site, coordinating media-fill protocols, validation, and QA with a focus on compliant aseptic manufacturing. The role emphasizes leadership, protocol development, and cross-functional collaboration to ensure accurate simulation of production practices.

The candidate will work with MQ and Aseptic Training teams, driving process improvements, training, and adherence to FDA 503B guidance and cGMP standards.

Qualifications

• Bachelor’s degree in Microbiology, Life Sciences, Engineering, or related discipline.
• Minimum 5 years in sterile pharmaceutical manufacturing or 503B
• Understanding FDA 503B guidance and cGMP for Sterile Drug Products
• Leadership and project management capabilities
• Excellent communication, problem-solving and decision-making skills
• Proficiency in electronic quality systems, deviation management, and protocol/report authorship
• Quality-driven, detail-oriented mindset with regulatory awareness
• Ability to lead cross-functional teams and drive continuous improvement

Responsibilities

• Coordinate APS activities with Validation, Production and QA to ensure compliance and efficiency for 503B facilities.
• Develop and approve media fill protocols modeling production operations and equipment configurations.
• Oversee planning and execution of 2–4 media fills per month with adherence to procedures and aseptic technique.
• Coordinate cross-functional support from manufacturing, quality control, and facilities.
• Ensure timely documentation, investigations, and closure of deviations or anomalies.
• Support Aseptic Training to analyze performance trends and improve aseptic practices.
• Ensure training and qualification in aseptic technique and gowning for APS personnel

Skills

Leadership

Project management

Communication

Problem solving

Decision making

Electronic quality systems

Deviation management

Protocol writing

Data integrity

Regulatory awareness

Cross-functional teamwork

Education

Bachelor's degree in Microbiology/Life Sciences/Engineering

Tools

GxP systems

Job description

Fagron is seeking an Aseptic Process Specialist to organize APS activities at a 503B site, coordinating media-fill protocols, validation, and QA with a focus on compliant aseptic manufacturing. The role emphasizes leadership, protocol development, and cross-functional collaboration to ensure accurate simulation of production practices.

The candidate will work with MQ and Aseptic Training teams, driving process improvements, training, and adherence to FDA 503B guidance and cGMP standards.