Sterility assurance engineer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8i71lz

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/8i71lz