Senior Validation SME - Aseptic Process Simulation

Key Responsibilities

• Develop and maintain the overall Media Fill (APS) strategy, including risk-based worst-case scenarios.
• Define simulation requirements and interventions based on regulatory expectations and industry standards.
• Plan, oversee, and document media fill studies from start to finish.
• Investigate deviations, perform root cause analyses, and initiate corrective actions or revalidation when necessary.
• Partner with Manufacturing, Quality Assurance, Engineering, MS&T, Microbiology, and Quality Control teams.
• Incorporate Environmental Monitoring (EM) data into the APS program.
• Ensure validation activities comply with GMP requirements and global regulations.
• Support audits, inspections, regulatory submissions, and responses to health authorities.
• Create and manage Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs.
• Create and maintain validation procedures, protocols, reports, templates, and work instructions.
• Perform hands-on validation work, including protocol writing, execution, data analysis, and report preparation.

General Expectations

• Demonstrate integrity, accountability, and sound judgment.
• Maintain a positive, professional attitude.
• Follow all regulatory requirements related to cell and gene therapy products.
• Pay close attention to detail and quality.
• Manage multiple projects, investigations, and documentation assignments simultaneously.
• Identify, solve, and prevent operational problems.
• Support audits, customer interactions, and inspection readiness activities.

Qualifications

• Bachelor's, Master's, or Ph.D. degree in Life Sciences, Biotechnology, Gene Therapy, or a related field.
• 5–8 years of relevant experience, including at least 3 years supporting commercial drug product filling operations.
• Strong expertise in:
• Aseptic Process Simulation (Media Fills)
• Process Validation
• Contamination Control
• Risk Assessment and Analysis
• Knowledge of GMP regulations and industry standards, including FDA, EU GMP Annex 1, PIC/S, and ISO 13408-1.
• Understanding of sterilization, aseptic processing, and first-air principles.
• Experience in biologics or gene therapy manufacturing, preferably with isolator technology or other closed systems.
• Strong communication, project management, and organizational skills.
• Proficiency in Microsoft Office (Word, Excel, and PowerPoint).
• Ability to work effectively both independently and within cross-functional teams.
• Strong customer focus and ability to handle confidential information professionally.