Process & Cleaning Validation Specialist Ii Lazio

Process & Cleaning Validation Specialist Ii
Roma
Lazio, Lazio

Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office About Thermo Fisher Scientific Inc. Thermo Fisher Scientific Inc. is a global leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer.

As one team of 100, 000+ colleagues, we are committed to accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need.

We value diverse experiences, backgrounds, and perspectives, and foster a collaborative and inclusive work environment.

**Process & Cleaning Validation Specialist II**: As a Process & Cleaning Validation Specialist II at Thermo Fisher Scientific, you will have the opportunity to be part of a world-class team and contribute to the flawless validation of manufacturing processes and cleaning procedures.

Your expertise and proven experience will play a crucial role in ensuring the production of high-quality pharmaceutical products that meet strict regulatory requirements.

**Responsibilities**: - Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes - Develop protocols and conduct process validation for product manufacturing and aseptic filling (Media fill) - Perform cleaning validation of cleaning procedures and ensure periodic cleaning verification - Manage validation protocols for cleaning, process, and Media Fill - Collaborate with other departments to define protocol contents and actions to be carried out - Validate manufacturing processes, cleaning procedures, and APS/Media Fill - Support the drafting and approval of documents for new product transfer and validation - Handle deviations related to validation activities - Ensure accurate execution of validation activities and detailed analysis of results - Draft validation reports and ensure proper archiving of all documentation - Provide quality support for new product transfer and process qualification - Actively participate in the design, construction, and implementation of new processes or manufacturing departments **Requirements**: - Bachelor's Degree or equivalent in a scientific/pharmaceutical area - 2 years of previous related experience in the pharmaceutical sector - Knowledge of pharmaceutical techniques, production, and aseptic filling processes - Experience in risk management and client service/project management - Proficiency in Microsoft Office software - Fluent in English with advanced written and oral communication skills