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Joan O'Malley
Life Science

0871897333
[email protected]
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Details

Site Microbiologist EO Sterilisation


Reference:JOM AGPI-070703 Location: Roscommon
Westmeath
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Microbiologist, Sterilisation Analyst



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
  • 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
  • Meets and occasionally exceeds the duties and responsibilities of the job and of Medtronic Core Competencies
  • All activities must be performed in compliance with the Quality System
Education
Bachelor of Science degree required (Level 8). Master’s degree in Microbiology or other life sciences is preferred.
5+ years of medical device industry experience in microbiology and sterilization


Required Knowledge
  • General math, general and analytical chemistry knowledge
  • Microbiology laboratory skills
  • Knowledge of Ethylene Oxide Sterilisation as per ISO 11135. This includes validations, re-qualifications, and routine production.
  • 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.
  • Basic math, algebraic math, with ability to calculate serial dilutions, scientific exponents, proportional concentrations and graphing skills.
  • Knowledge of Cleanroom environmental monitoring.
  • Computer skills
  • Good oral and written communication skills
Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role. Contact Joan O’Malley at 087-1897333