Graduate Sterility Assurance Scientist / Engineer

at  GE Healthcare

SUMMARY:

The Graduate Sterility Assurance Engineer will largely be involved in the sterilisation process from an engineering perspective, ensuring that the sterilisation equipment is maintained in a validated state and that rigorous change control is applied. Systems that ensure controlled performance will be established and monitored so that any deterioration can be detected before sterilisation performance is affected.
The position requires close co-ordination and cooperation with the Sterility Assurance Lead and all Quality, Engineering, Operation and Validation personnel.

PRINCIPAL QUALIFICATIONS/SKILLS AND WORK EXPERIENCE REQUIRED:

• Graduate in an Engineering or Science discipline
• Good PC Skills and Computer literate.
• Good communication and motivation skills.
• Familiarity with working in a GMP environment.
• Ability to both work alone and with a team.

• Monitoring performance of the sterilisation equipment to ensure any deterioration does not affect sterilisation performance.
• Leading cross functional teams and working alone to execute upgrades, process improvements and projects related to the sterilisation process and equipment.
• Co-ordinate/ perform equipment CIP & SIP studies.
• Assessing planned and unplanned maintenance on the sterilisation equipment to ensure there has been no effect on sterilisation performance.
• Preparation executions of URS, FDS, IQ, OQ, PQ protocols.
• Project management of small to medium site specific capital projects through from conception, approval, planning to execution and validation. Management of and liaising with equipment vendors and contractors.
• Trouble shooting providing continuous technical support on the sterilisation processes in conjunction with the maintenance, Validation, production and Quality Departments.
• Ensure compliance with current technical, engineering and regulatory standards and guidelines.
• Executions of re-qualification studies and reviews of qualification studies on Sterility Assurance equipment.
• Engage with Trackwise software to perform investigations, deviations etc.
  DISCLAIMER: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned.