Aseptic Process Simulation Program Coordinator

Job description

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. Bachelor’s degree in science or technical field. MBA degree is beneficial and preferred. 5-10 years of experience in areas such as supply chain, customer service, manufacturing, engineering, and project management. Broad business perspective, knowledge and understanding of manufacturing processes. Strong project experience and an ability to influence others are essential. Strong Strategy development and planning skills coupled with necessary knowledge of pharmaceutical manufacturing and supply activities. Strong issue identification and problem analysis, with the ability to create and execute solutions based on the gathered data. Proficiency with common program management communication software tools and techniques. Knowledge of business financial systems and tools. Collaborative approach in working with different teams and stakeholders in a globally oriented work environment Proven leadership ability with excellent communication skills including listening, verbal presentation and written.