Sterility assurance engineer

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