The APS/Media Fill Program Lead for a sterile ophthalmic manufacturing site in Waco, TX, leads the site-wide program in alignment with current GMP, FDA, EU Annex 1, and AbbVie quality standards, developing and executing the annual strategy, overseeing protocols and documentation, coordinating cross-functional execution, and serving as the subject matter expert for investigations and inspection readiness. [1] [2] The role also covers trend analysis, personnel qualification integration, CAPA and continuous improvement, regulatory and customer-audit support, technical leadership, mentorship, and monitoring industry and regulatory developments to strengthen contamination control and aseptic operations

For an Aseptic Process Simulation (Media Fill) Program Lead supporting a sterile ophthalmic manufacturing site in Waco, TX, the responsibilities could include:

Key Responsibilities

• Lead the site-wide Aseptic Process Simulation (APS/Media Fill) program to ensure compliance with current GMP, FDA, EU Annex 1, and AbbVie quality standards for sterile eye care manufacturing.
• Develop, maintain, and execute the annual media fill strategy, including routine, validation, and intervention-based process simulations.
• Serve as the subject matter expert (SME) for aseptic process simulation design, execution, investigation, and regulatory inspection readiness.
• Collaborate with Manufacturing, Quality Assurance, Microbiology, Engineering, and Validation teams to ensure media fills accurately represent routine and worst-case manufacturing conditions.
• Author, review, and approve APS protocols, risk assessments, reports, and associated quality system documentation.
• Lead investigations, root cause analyses, and corrective and preventive actions (CAPA) related to media fill failures or atypical events.
• Analyze APS performance metrics and trends to identify opportunities for continuous improvement and enhanced contamination control.
• Ensure personnel qualification and requalification programs are effectively integrated with media fill requirements and aseptic practices.
• Support regulatory inspections and customer audits by presenting APS program strategies, results, investigations, and compliance initiatives.
• Drive continuous improvement initiatives related to contamination control, aseptic processing, and sterile manufacturing operations.

Preferred Leadership Focus

• Provide technical leadership and mentorship for cross-functional teams involved in sterile manufacturing and contamination control.
• Champion a culture of quality, compliance, and operational excellence across aseptic processing operations.
• Monitor industry trends, regulatory expectations, and emerging best practices to continuously strengthen the site's APS program.