Sterilisation Engineer

STERILISATION ANALYST / ENGINEER

(Ref No: 24_12)

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 is a permanent full-time position and 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 would like to apply for this vacancy, please apply via our recruitment portal before the closing date of 5pm on Sunday, 12th May 2024 .    

Please note we are unable to offer support for VISAs/Sponsorship for this role.