Sterilisation Engineer
Terumo Blood and Cell Technologies
full-time
Posted on:
Location Type: Office
Location: Larne • United Kingdom
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About the role
- 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.
Requirements
- 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.
- 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.
Benefits
- full training will be provided for this role
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
autoclave sterilisation cycle developmentprocess qualificationvalidation documentationstatistical process controlcalibration of process equipmentmeasurement instrumentationGMP documentationmoist heat sterilisationIQ/OQ/PQ execution
Soft Skills
strong communication skillswriting skillstime managementplanning skillsability to work under pressureability to meet strict deadlines
Certifications
degree in Microbiologydegree in Biology Sciencedegree in Chemical Engineeringdegree in Biomedical Engineering