Aseptic Process Simulation

Job SummaryThe Senior Validation Specialist, Aseptic Process Simulation is responsible for developing, executing, and continuously improving the Aseptic Process Simulation (Media Fill) program to ensure compliant and reliable aseptic manufacturing operations. This role leads media fill strategy, validation activities, and process performance programs while partnering with Manufacturing, Quality, Engineering, Microbiology, and Regulatory teams to support GMP compliance and successful inspections. The position also supports Process Performance Qualification (PPQ), Continued Process Validation (CPV), and contamination control initiatives for biologics and gene therapy manufacturing.ResponsibilitiesDevelop and maintain the Aseptic Process Simulation (Media Fill) strategy, including risk-based worst-case scenarios and validation approaches.Plan, execute, oversee, and analyze Media Fill studies, ensuring timely completion and accurate documentation.Define routine and non-routine interventions in accordance with FDA, EU GMP Annex 1, ISO 13408-1, and PIC/S guidance.Lead deviation investigations, root cause analyses, corrective actions, and revalidation activities as needed.Develop, implement, and maintain PPQ and CPV programs, including protocols, reports, procedures, and supporting documentation.Perform hands-on validation activities, including protocol development, execution, data analysis, and technical report writing.Collaborate with Manufacturing, Quality Assurance, Engineering, MS&T, Microbiology, and QC to support validation, contamination control, and Environmental Monitoring strategies.Ensure validation activities comply with GMP requirements, quality systems, and regulatory expectations.Support internal and external audits, regulatory inspections, and personnel training on validation and aseptic practices.Manage multiple validation projects while maintaining high standards of quality, integrity, and attention to detail.QualificationsBachelor's, Master's, or Ph.D. in Life Sciences, Biotechnology, Engineering, or a related field.5–8 years of validation or aseptic manufacturing experience, including at least 3 years supporting commercial drug product filling.Demonstrated expertise in aseptic process simulation (Media Fill), process validation, contamination control, and risk assessment.Working knowledge of FDA, EU GMP Annex 1, ISO 13408-1, PIC/S, and other applicable regulatory requirements.Experience with biologics, cell or gene therapy manufacturing, including isolator technology or closed-system processing.Strong understanding of sterilization, first air, aseptic technique, and Environmental Monitoring principles.Experience supporting PPQ, CPV, validation documentation, investigations, and regulatory inspections.Proficient in Microsoft Office, including Excel, Word, and PowerPoint.Ability to work independently, manage multiple priorities, and collaborate effectively in a cross-functional GMP environment.