Aseptic Process Validation Specialist

Fagron Group; Wichita (KS); On-site; USD 70,000 - 90,000; Full time

Job summary

Fagron Group is seeking an Aseptic Process Validation Specialist in Wichita, Kansas, to plan and execute aseptic process simulations (media fills). You will ensure compliance with regulatory requirements and lead initiatives for continuous process improvements.

The role involves documentation, team coordination, and risk assessment to enhance aseptic operations. Strong knowledge of cGMP and FDA regulations is required. This role offers an opportunity to impact quality and safety in aseptic processing.

Qualifications

• Strong knowledge of cGMP, FDA, and other relevant regulatory requirements.
• Excellent organizational and project management skills.
• Proficiency in data analysis and technical writing.

Responsibilities

• Plan, schedule, and execute aseptic process simulations in accordance with regulatory guidelines.
• Prepare and maintain comprehensive records of media fill protocols and results.
• Ensure APS activities comply with cGMP, regulatory, and company standards.
• Collaborate with production, quality, and validation teams.
• Analyze APS outcomes to identify process gaps or improvement opportunities.

Skills

Knowledge of cGMP

Data analysis

Project management

Technical writing

Job description

About the Job

The Aseptic Process Validation Specialist is responsible for planning, executing, and overseeing aseptic process simulations (media fills) to ensure compliance with regulatory requirements and internal quality standards. The role involves coordinating cross‑functional teams, documenting processes, analyzing results, and driving continuous improvement initiatives in aseptic operations.

Key Responsibilities

• Process Simulation Execution:
• Plan, schedule, and execute aseptic process simulations (media fills) in accordance with regulatory guidelines (e.g., FDA, Boards of Pharmacy).
• Ensure the sterile environment and practices adhere to validated aseptic techniques.
• Documentation and Reporting:
• Prepare and maintain comprehensive records of media fill protocols, results, and deviations.
• Generate and present reports summarizing APS findings, trends, and corrective actions to management.
• Compliance and Quality Assurance:
• Ensure APS activities comply with cGMP, regulatory, and company standards.
• Act as a liaison during internal and external audits related to aseptic processing.
• Team Coordination:
• Collaborate with production, quality, and validation teams to ensure readiness for APS activities.
• Train personnel on aseptic techniques and media fill protocols.
• Continuous Improvement:
• Analyze APS outcomes to identify process gaps or improvement opportunities.
• Propose and implement corrective and preventive actions (CAPA) to enhance aseptic processes.
• Risk Assessment and Troubleshooting:
• Perform risk assessments related to APS execution and aseptic processing.
• Troubleshoot issues encountered during simulations and ensure timely resolution.
• Key Performance Indicators (KPIs)
• Timeliness and compliance of APS execution.
• Accuracy and completeness of APS documentation.
• Reduction in APS‑related deviations and implementation of CAPA.
• Continuous improvement in aseptic process efficiency.

Basic Qualifications

• Strong knowledge of cGMP, FDA, and other relevant regulatory requirements.
• Excellent organizational and project management skills.
• Proficiency in data analysis and technical writing.