Aseptic Process Simulation Program Coordinator

Role: Aseptic Process Simulation (Media Fill) Program Lead at a sterile ophthalmic manufacturing site in Waco, TX, responsible for overseeing site-wide aseptic process simulation programs to ensure compliance with GMP, FDA, EU Annex 1, and AbbVie standards. Objectives include developing and executing annual media fill strategies, ensuring validation and routine process simulations, and maintaining inspection readiness. Core responsibilities involve collaborating cross-functionally with Manufacturing, Quality Assurance, Microbiology, Engineering, and Validation teams; authoring protocols, risk assessments, and reports; leading investigations and CAPAs related to media fill events; analyzing performance metrics for continuous improvement; and supporting regulatory inspections and audits. The role emphasizes technical leadership, mentorship, and fostering a culture of quality and compliance, with a focus on contamination control and aseptic processing enhancements. Qualifications required include a Bachelor’s in science or technical field (MBA preferred), 5-10 years of experience in manufacturing, engineering, or related areas with project management and strategic planning skills. Knowledge of pharmaceutical manufacturing, supply chain, and regulatory requirements is essential. The position demands strong problem-solving, communication, and collaborative skills within a global manufacturing environment. High-value specifics include focus on sterile ophthalmic products, aseptic process validation, contamination control, GMP compliance, and industry best practices. The role may involve engagement in inspection readiness and continuous process improvement initiatives.