Aseptic Process Validation Specialist

Fagron; Wichita (KS); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision, and dental insurance

Health savings account (HSA)

Paid time off

Job summary

Fagron, located in Wichita, Kansas, is seeking an Aseptic Process Validation Specialist responsible for planning and executing aseptic process simulations to ensure compliance with regulatory and internal quality standards. This role involves documenting results, analyzing variations, and leading continuous improvements in aseptic operations.

The ideal candidate will work in a cleanroom environment and possess strong knowledge of cGMP and FDA requirements, excellent organizational skills, and proficiency in data analysis.

Fagron offers competitive salaries, benefits including a 401(k) with matching, medical, vision, dental, and opportunities for personal and professional growth.

Qualifications

• Strong knowledge of cGMP, FDA, and relevant regulations.
• Excellent organizational skills.
• Effective interpersonal collaboration.

Responsibilities

• Plan and execute aseptic process simulations.
• Maintain records of protocols and results.
• Ensure compliance with cGMP and regulatory standards.
• Collaborate with teams on APS activities.
• Analyze outcomes for process improvements.
• Perform risk assessments and troubleshooting.

Skills

Knowledge of cGMP

Project management skills

Data analysis proficiency

Effective communication

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.
• Effective communication and interpersonal skills for cross‑functional collaboration.

Working Conditions

• Work in cleanroom environments requiring adherence to strict gowning procedures.
• Ability to work flexible hours to accommodate media fill schedules.

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, a 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.