Sterility assurance engineer
4 giorni fa
Monza, Lombardia, Italia
CAI
Tempo pieno
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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
* 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