Aseptic Process Validation Lead

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

Job summary

Fagron Tech in Wichita, Kansas, is seeking an Aseptic Process Validation Specialist responsible for planning and executing aseptic process simulations to ensure compliance with regulatory requirements and internal standards.

The ideal candidate will coordinate teams, document processes, and drive continuous improvement. Strong knowledge of cGMP and FDA regulations is essential, along with proficiency in data analysis and project management.

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.
• Prepare and maintain records of media fill protocols.
• Ensure APS activities comply with cGMP and regulatory standards.
• Collaborate with production, quality, and validation teams.
• Analyze APS outcomes to identify process gaps.

Skills

Knowledge of cGMP

Project management skills

Data analysis

Technical writing

Job description

Fagron Tech in Wichita, Kansas, is seeking an Aseptic Process Validation Specialist responsible for planning and executing aseptic process simulations to ensure compliance with regulatory requirements and internal standards.

The ideal candidate will coordinate teams, document processes, and drive continuous improvement. Strong knowledge of cGMP and FDA regulations is essential, along with proficiency in data analysis and project management.