Process and Cleaning Validation Specialist II

1 settimana 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.

Job Summary

We are seeking a highly skilled Process and Cleaning Validation Specialist II to join our team. As a key member of our manufacturing operations, you will be responsible for ensuring the flawless validation of manufacturing processes and cleaning procedures.

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.


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