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Process Validation and Sterility Assurance Expert

2 settimane fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

About the Role

We are seeking an Aseptic Process Validation Specialist to join our team in Monza. In this role, you will be responsible for supporting the Supervisor, MS&T Process & Cleaning Validation, and contributing to the management of the aseptic process validation.

Your Key Responsibilities:

  • Issuing validation procedures, protocols, and reports for Media Fill exercises
  • Designing processes for manufacturing sterile lyophilized and liquids drug products (vials, pre-filled cartridges or syringes) under RABS systems or isolators
  • Analyzing technical documentation related to new product introduction
  • Issuing manufacturing instructions (MBR) for validation batches

You Will Be Working Closely With:

  • Project Managers
  • Process Validation Teams
  • Client Technical Teams

We Offer:

  • A supportive work environment with opportunities for growth and development
  • Collaboration with experienced professionals in the field
  • The chance to contribute to the Company's mission to improve people's lives through advanced technologies

What We Look For:

  • Degree in Pharmacy, Chemistry, Biotechnology, Biology, or similar scientific degrees
  • Previous experience in validation is helpful
  • Proficient in English (both written and spoken)
  • IT knowledge: Company IT systems (PMX, LIMS, Trackwise, Minitab) and Microsoft Office tools