Terumo Aortic are currently looking to recruit a Microbiology & Sterilisation Engineer to join our Quality Assurance team. This is an excellent opportunity to join a global organization during a period of investment and growth with fantastic career opportunities.
The main responsibilities of the role are;
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- Laboratory Information Management System (LIMS) administration
- Validation/change management of LIMS and other required computer systems
- Validation and/or support validation of cleanrooms/controlled environments
- Development of Quality plans for any works impacting cleanrooms of controlled areas
- Validation and/or support validation of steriliser processes in accordance with BS EN ISO 11135 & BS EN IS0 11137
- Validation of equipment and test method
- Support site improvement/investment activities
- Support and compliance with change and document control processes
- Provide computer systems validation support
- Purchasing/Validation of equipment
- Continuous improvement activities
- Raise, investigate, and complete non-conformance as required
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The successful candidate will possess;
- Life Science/engineering degree or other relevant scientific discipline
- Experience within quality system-controlled microbiology lab
- Experience of steriliser and cleanroom validations
- Working knowledge of computer system validation requirements
- Working knowledge of quality computer systems applications
- Thorough knowledge of regulatory standards, Quality Management Systems, and global regulations for medical devices
- Strong analytical and problem-solving skills, including appropriate use of statistical techniques
- Proven ability to manage and prioritise workload, meet deadlines and work in a pressurised environment
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