Position Overview

Leads multiple quality assurance projects and activities to support the sterility requirements of medical products. Leads sterilization process commissioning, initial sterilization validation and re-validation activities. Provides technical leadership for sterilization and environmental control activities.Typical duties to include:
  • Performs commissioning of new Ethylene oxide and steam sterilizers
  • Coordinate with vendors, Facilities team, and Operations team for utility installation, IQ/OQ activities, and permitting functions for in-house sterilization
  • Lead and conduct cycle development activities for in-house Ethylene oxide sterilization, including, but not limited to:
    • Determine loading configurations. Determine sterilization cycle parameters based on fractional cycle approach. Identify appropriate PCD configurations, resistance hierarchy, and required quantity for validation.
    • Identifies sterilization validation approach to meet regulations and conducts such validations for new processes as well as revalidations
  • Lead and conduct annual revalidations for steam sterilization and EtO sterilization processes. Work closely with Operations and Quality Engineering teams to coordinate and execute revalidation activities.
  • Generates project plans, validation master plans, test protocols and reports for sterilization validation
  • Coordinates microbiological testing performed in-house and by outside laboratories, to support validation studies
  • Works with new product development teams on establishing sterilization strategies for steam, heat, radiation, and ethylene oxide sterilization
  • Provides sterilization expertise during interface with regulatory agencies, including FDA and ISO
  • Support Quality Engineering Manager to facilitate clean room monitoring activities
  • Provide sterilization expertise and write-ups to support NCRs and/or CAPAs
  • Identify budgets for sterilization validation activities
  • Other duties as assigned
    1. Bachelor’s Degree in related field or equivalent.
    2. Six (6+) years of related experience.
    3. Three (3+) years sterilizer commissioning / cycle development experience.
    4. Past leadership or supervisory experience
    Desired Qualifications
    1. Advanced degree
    2. Excellent command of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring
      • EN ISO 11135, EN ISO 11137, EN ISO 17665, EN ISO 14644, EN ISO 14698, etc.
    3. Working knowledge of various sterilization processes including steam, heat, radiation, ethylene oxide.
    4. Experience working with biological indicators (BI’s) and conducting microbial testing.
    5. Experience in Ethylene oxide cycle development.
    6. Experience with parametric release validations and requirements.
    7. Good project management skills.
    8. Good test protocol and report writing abilities.
    9. Ability to prepare project plans involving multiple concurrent activities.
    10. Skill determining root causes of unanticipated high microbial or pyrogen levels on products .
    11. Skills in generating write-ups to support NCRs and/or CAPAs.
    12. Past experience participating in FDA and ISO audits to explain and defend sterilization program .
    13. Ability to program and extract data from temperature/pressure data loggers.
    14. Ability to operate sterilization equipment.
    15. Extract data, and complete analysis of temperature data.
    16. Experience working with laboratory testing vendors.
    17. Good communication skills, both written and oral.
    18. Ability to manage multiple projects simultaneously, stay organized, effectively manage obstacles and drive projects to completion.
    19. Ability to provide concise project updates as requested.
    20. Ability to actively collaborate with other departments.
    21. Computer skills including Word, Excel, and data logging software.