Sterility assurance engineer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8hy2st

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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8hy2st