Aseptic Process Specialist

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

About the Job

The Specialist for the Aseptic Process Simulation Program organizes all aspects of aseptic process simulation (APS) activities at the 503B outsourcing facility. This individual 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.

The Aseptic Process Specialist works with the Validation department manager to ensure that all APS events are scientifically sound, compliant with FDA 503B guidance, cGMP Guidance for Sterile Manufacturing, and other relevant rules and guidelines, and that they accurately simulate routine production practices. The coordinator will report to Manufacturing Quality (MQ) and work with the MQ Aseptic Training team to improve aseptic processes.

Key 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.

Basic 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.
• UnderstandingofFDA 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.
• Proficiencyin 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

What's on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready for the challenge?

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.