Sterility assurance engineer

1 giorno fa

Monza, Lombardy, Italia CAI Tempo pieno
Overview

In this role, you support sterility and aseptic processing activities within CAI’s life sciences and mission-critical projects. You will apply microbiological methods, ensure compliance with GMP and Good Documentation Practices, and contribute to sterile manufacturing initiatives. The role collaborates with cross-functional teams to execute field-driven validation and documentation, driving quality and operational readiness. This is a hands-on position offering exposure to global projects and travel, with a clear impact on product quality and patient safety.

Responsabilità
  • Apply microbiological methods and validation within sterile manufacturing
  • Ensure adherence to GMP, GDxP, and Good Documentation Practices
  • Work with Annex 1 requirements and sterile processing principles
  • Perform aseptic techniques and operate safety cabinets
  • Manage priorities independently and maintain attention to detail
  • Coordinate activities and support field execution when needed
  • Maintain documentation and reporting for quality systems
Requisiti fondamentali
  • Proficient in spoken and written English
  • Strong technical writing and documentation skills
  • Ability to work autonomously and proactively
  • Willingness to travel domestically and internationally
  • Strong communication and stakeholder management
  • Cross-functional collaboration
  • Organizational and problem-solving skills
  • Microbiological methods and validation
  • GMP regulations and Good Documentation Practices
  • Annex 1 requirements and sterile manufacturing principles