STERILISATION ANALYST / ENGINEER (Ref No: 25_04) Terumo BCT Ltd - located in Larne - manufactures a range of sterile fluids for human and veterinary use. A vacancy currently exists for a CQV Sterilisation Analyst / Engineer. The successful candidate will perform validation of the terminal sterilisation processes. We are currently looking for candidates to join the Sterilisation Validation Department. This role is a part time position for 3 days/week for one year contract. Full training shall be provided for this role. Duties will include: Autoclave sterilisation cycle development, validation and annual re-qualification of cycles. Process qualification including all areas of the validation life cycle. Operation of steam and superheated water autoclaves. Generation and completion of validation documentation (protocols and reports) and assist in the execution of qualifications such as IQ/OQ/PQ. Recording and analysis of process data including use of statistical process control techniques. Investigation, reporting and reviewing of results. Calibration of process equipment and measurement instrumentation. Working with cross function departments on all aspects of the sterilisation process. To ensure that good GMP/QMS standards are maintained at all times. Applicants must possess: A degree or equivalent qualification in Microbiology/Biology Science or Engineering, e.g. Chemical or Biomedical Engineering. Strong communication and writing skills. Good time management and planning skills. Ability to work under pressure and to strict deadlines (this role may necessitate working additional hours and/or shifts, including weekend shifts as and when required. In addition, the following would be a distinct advantage: Experience within a Pharmaceutical or Medical Device environment. Knowledge of moist heat sterilisation and regulations. A track record of carrying out and executing GMP documentation. Experience gained within a production/manufacturing environment. If you're ready to make a significant impact in a dynamic and collaborative environment, we invite you to apply for this exciting opportunity. Please submit your CV viaour Terumo BCT careers portal mySource before the closing date of5:00 pm on Friday, 28 February 2025. You must clearly demonstrate on your CV / application how you meet the required criteria as failure to do so may result in you not being shortlisted. Join us in driving progress and supporting patients locally and across the globe every day by Contributing to Society Through Healthcare Skills: Strong communication skills Writing Skills Time Management Planning Benefits: Group Life Assurance Paid Holidays Performance Bonus Pension Plan Health Care Cash Plan