Job Seekers

Sterilization Sciences Specialist

Twitter Facebook
Job Type
Direct Hire
Nov 14, 2016
Job ID
Sterilization Sciences Specialist
Essential Duties and Responsibilities:
  • Participate in design review meetings and as a key member of product design teams to assess and validate devices for proper sterilization methods, e.g., radiation, ethylene oxide, etc.;
  • Generate assessments and/or validations for new device introduction or process/product changes for impact to sterilization and end-user cleaning using microbiological and sterilization theories and practices according to applicable ISO requirements.
  • Generate and execute protocols for sterilization processes (i.e. EO, Gamma, Steam, etc.) and equipment validation, along with reports and conclusions.
  • Direct and maintain global corporate programs for sterilization cycle maintenance and end-user cleaning and sterilization instructions;
  • Ensure corporate sterilization and biological safety programs are maintained in accordance with all relevant international standards, e.g., ISO 11135, ISO 11137, ISO 17665, ISO 10993, etc. as well as domestic and foreign regulatory requirements;
Education and Experience:
Bachelor’s degree in industrial science, engineering, biology/microbiology, or related science field required. 
Minimum 5 years-experience in sterilization validation/assessment, or related fields, for the medical device industry is required.