Process Validation Specialist

1 mese fa


Ferentino, Lazio, Italia Thermo Fisher Scientific A tempo pieno
Job Summary

We are seeking a highly skilled Process & Cleaning Validation Specialist II to join our team at Thermo Fisher Scientific. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our manufacturing processes and cleaning procedures.

Key Responsibilities
  • Evaluate manufacturing process documents and equipment cleaning procedures to ensure compliance with regulatory requirements.
  • Develop and implement process validation protocols for product manufacturing and aseptic filling.
  • Perform cleaning validation of cleaning procedures and ensure periodic cleaning verification.
  • Manage validation protocols for cleaning, process, and media fill.
  • Collaborate with cross-functional teams to define protocol contents and actions to be carried out.
  • Validate manufacturing processes, cleaning procedures, and aseptic filling processes.
  • 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.
Requirements
  • Bachelor's Degree or equivalent in a scientific or 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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