Description
Our global medical device client is currently seeking a Sterility Assurance Engineer to be involved in the sterilisation processes from an engineering perspective. The successful contractor will be responsible in ensuring that the sterilisation equipment is maintained in a validated state and that rigorous change control is applied.The Sterility Assurance Engineer will work closely with the Utilities Process Engineer to manage the quality and performance of pure steam and other WFI equipment and perform Sterility Assurance activities.
Responsibilities:
- Monitoring sterilisation equipment to ensure any deterioration does not affect sterilisation performance.
- Assessing unplanned and planned maintenance on the sterilisation equipment to ensure there has been no effect on sterilisation performance.
- Preparation & execution of lifecycle validation and sterility assurance documentation e.g. data review, plans, protocols, reports.
- Troubleshooting and providing continuous technical support on the sterilisation processes in conjunction with the Maintenance, Validation, Production and Quality Departments.
- Aware of and ensuring compliance with current technical, engineering and regulatory standards and guidelines.
- Develop specific performance metrics for clean utilities, focusing on generation, yield, uptime, and compliance (quality, safety, environmental).
Qualifications/Requirements
- Degree in Engineering, or similar.
- Extensive engineering experience, working with sterilisation systems and processes in a regulated industry or similar.
- Good knowledge and experience with technical documentation and Sterilisation Standards.
If this long term opportunity, paying competitive rates, working with cutting edge technology is of interest, then please contact me immediately.