Thermo Fisher Scientific seeks a Process & Cleaning Validation Specialist for a fixed-term maternity leave replacement role in Ferentino, Italy. The position focuses on developing and executing validation protocols for manufacturing processes, cleaning procedures, and aseptic filling operations while ensuring regulatory compliance and GMP standards.
Responsibilities
- Develop and draft validation protocols for cleaning, manufacturing processes, and media fill activities
- Execute periodic cleaning verification and aseptic filling validations according to SOPs and regulations
- Conduct process qualification and continued process verification using lifecycle approach methodology
- Oversee validation batch operations and prepare comprehensive validation reports with accurate data analysis
- Manage deviations related to validation activities and support new product transfer initiatives
Requirements
- Bachelor's degree in pharmaceutical, chemistry, biotechnology, or related scientific field
- At least 3 years direct experience in process validation and cleaning validation for sterile products
- Knowledge of aseptic filling processes and risk management methodologies
- Proficiency in Microsoft Office software and project management
- Basic Italian language skills and advanced English written and oral communication
- Experience with pharmaceutical production techniques