Process & Cleaning Validation Specialist - Fixed Term (Replacement For Maternity Leave)

06 ott - Lazio
Thermo Fisher Scientific

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

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