Job Detail

Location Athlone
Salary Negotiable
Posted
Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie

Senior Sterilisation Engineer

Senior Sterilisation Engineer

A lead medical device company in the midlands is looking to hire a Senior Sterilisation Engineer on a permanent basis. This role is based in Westmeath which is commutable from Galway, Roscommon and Meath. In this role, you will be responsible for completion of sterilization validations and cleanroom microbiological evaluations. You will provide technical guidance to engineers and project management. This position requires knowledge of ethylene oxide sterilization per ISO 11135 and the Microbiologist should have strong report writing skills.

Key Responsibilities

  • Manages the sterilization and microbiological testing necessary to meet manufacturing and regulatory requirements
  • Responsible for maintaining compliance to all regulations and standards relevant to job responsibilities
  • Manage technical projects from protocol development, laboratory testing, data analysis through final report generation.
  • Manage environmental trending as required by regulations to ensure compliance for critical systems.
  • Develops, validates, and implements controlled environment methods
  • Perform various microbiological or chemical evaluations encompassing USP/AAMI biological testing, ETO residuals and other alternative sterilization methods
  • Provides technical support for new product development and manufacturing processes related to microbiological quality

Key Requirements

  • Bachelor of Science/Engineering degree or higher required.
  • 5+ years of medical device industry experience in microbiology and sterilization
  • Knowledge of Ethylene Oxide Sterilization as per ISO 11135. This includes validations, re-qualifications, and routine production.

Desired/Preferred Qualifications

  • Knowledge of industrial microbiology, microbiological quality control, medical device sterilization methods, and medical device GMPs.
  • Knowledge of applied microbiological theory and practices including inactivation kinetics, and medical device sterilization methods.
  • Microbiology laboratory skills including volumetric measurement, media preparation, microbial enumeration techniques, autoclave operation and laboratory safety.

For further information on this Senior Sterilisation Engineer role in Westmeath please contact Marchon Monroe on 086 044 9473/ talent@hero.ie

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Marchon Monroe

JOB-9660

Senior Sterilisation Engineer

Marchon Monroe

Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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