About the role
TL;DR
Ensures sterility assurance in manufacturing through microbiological methods and quality systems.
- •CAI is seeking a Sterility Assurance Engineer with experience in microbiological and biological methods to support clients in the Life Sciences industry.
- •This role involves ensuring adherence to quality systems and regulatory requirements in sterile manufacturing environments.
- •Key Responsibilities Experience with microbiological and biological methods, including method application and validation.
- •Understanding of quality systems, GMP regulations, and Good Documentation Practices.
- •Familiarity with Annex 1 requirements and sterile manufacturing principles.
- •Experience with aseptic techniques and biological safety cabinets.
- •Ability to work independently while managing multiple priorities.
- •Requirements Proficient in spoken and written English.
- •Strong technical writing and documentation skills.
- •Ability to work autonomously and proactively.
- •Willingness to travel domestically and internationally if required.
Domain expertise
healthcarebiotechconsulting