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Process and Cleaning Validation Specialist II

2 mesi fa

Roma, Lazio, Italia Thermo Fisher Scientific A tempo pieno

About Thermo Fisher Scientific

Thermo Fisher Scientific 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.

Job Summary

As a Process and 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.

Key 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