Process & Cleaning Validation Specialist I
Thermo Fisher Scientific seeks a Process & Cleaning Validation Specialist I in Ferentino, Italy to evaluate manufacturing processes and equipment cleaning procedures, develop validation protocols, and ensure compliance with regulatory requirements and GMP standards.
Responsibilities
Evaluate manufacturing process documents and equipment cleaning procedures to develop validation protocols
Draft validation protocols for cleaning, process, and media fill activities in collaboration with other departments
Conduct periodic cleaning verification and aseptic filling studies per SOPs and regulatory requirements
Execute process validation using lifecycle approach stages, analyze results, and prepare validation reports
Support new product transfers through validation phases and ensure accurate archiving of all documentation
Requirements
Bachelor's degree in pharmaceutical science, chemistry, pharmacy, biotechnology, or equivalent
Minimum 1 year direct experience in process validation, cleaning validation, or aseptic process simulation for sterile products
Knowledge of pharmaceutical production techniques and aseptic filling processes
Risk management experience
Proficiency in Microsoft Office software
Italian basic level and advanced English written and oral communication skills
Responsibilities
Evaluate manufacturing process documents and equipment cleaning procedures to develop validation protocols
Draft validation protocols for cleaning, process, and media fill activities in collaboration with other departments
Conduct periodic cleaning verification and aseptic filling studies per SOPs and regulatory requirements
Execute process validation using lifecycle approach stages, analyze results, and prepare validation reports
Support new product transfers through validation phases and ensure accurate archiving of all documentation
Requirements
Bachelor's degree in pharmaceutical science, chemistry, pharmacy, biotechnology, or equivalent
Minimum 1 year direct experience in process validation, cleaning validation, or aseptic process simulation for sterile products
Knowledge of pharmaceutical production techniques and aseptic filling processes
Risk management experience
Proficiency in Microsoft Office software
Italian basic level and advanced English written and oral communication skills