Permanent
Sterilisation Services Quality Engineer
Inchinnan

Microbiology & Sterilisation Engineer

Ref: 96| Posted: 24th Nov 2022

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;

 

  • 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

 

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