The board
- Hours
- Full-time
- Where
- Waco, TX
- Posted
- Sep 4
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:
What you'd do
- 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
What they want
- 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.
About AbbVie · Manufacturing
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.