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Sterilization Engineer

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Job Type
Direct Hire
Oct 10, 2016
Job ID

Sterilization Engineer
Main Objective:
Maintain Manufacturing sterilization process in accordance with Quality Systems Requirements.
 Essential Duties and Responsibilities:
  • Become proficient in the use and diagnostics of ethylene oxide sterilization equipment
  • Manage and maintain Manufacturing ethylene oxide sterilization cycles
  • Manage and maintain sterilization compliance with appropriate regulatory standards
  • Perform sterilization cycle evaluations and validations in conjunction with the Sterilization Science and Biological Safety Team
  • Perform audits of  Manufacturing suppliers, contract laboratories, and critical process suppliers when necessary.
  • Ensure proper maintenance of  Manufacturing files demonstrating vendor compliance and performance including authoring and/or reviewing sterilization validations and product adoptions into existing cycles in conjunction with the SSBS Team.
  • Recognize and address sterilization processing issues
  • Evaluate and optimize sterilization procedures including employee training
  • Implement and manage the “certified operator” training program.
  • Provide EH&S with timely communication on safety training and environmental compliance.
  • Track and trend sterilization non-conformances and processing metrics
  • Facilitate resolution of sterilization related MRB’s, non-conformances, and audit findings.
  • Provide assistance in assessing device design for ethylene oxide sterilization method when necessary.
  • Encourage a continuous process improvements environment
  • Support company business and expansion goals 
  • Education and Experience:
    Bachelor’s degree in industrial science, engineering, or related science field required
    3 years’ experience in sterilization, validation, medical device quality assurance, or related field required
    Knowledge and Skill Requirements/Specialized Courses and/or Training:
    Specialized training manufacturing operations, system design and development, industrial statistics, and technical writing preferred.
    Machine, Tools, and/or Equipment Skills:
    Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company). Experience with Solidworks, Minitab, and corporate ERP systems preferred.