Sterility Assurance Engineer
Pubblicato il 14-09-2026 - Cai in Varese
OverviewIn 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.
ResponsabilitàApply 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 fondamentaliProficient 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