Aseptic Process Validation Specialist

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. Document preparation and maintenance of 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.

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; health savings account (HSA); holiday/paid time off.

• We work in an open, dynamic environment where your ideas and talents can shine.

At Fagron

• We are an equal opportunity employer committed to creating a diverse environment and ensuring 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.