Aseptic Process Validation Lead

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

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.