Position Overview

Support multiple quality assurance projects and activities to meet the sterilization validation requirements of medical products. Lead sterilization process commissioning, initial sterilization validation and re-validation activities. Provide technical support for sterilization and environmental control activities. Job duties:
  • Conduct revalidations for steam, Ethylene Oxide, and radiation sterilization processes. Work closely with Operations and Quality Engineering teams to coordinate and execute revalidation activities.
  • Conduct technical justifications and physical studies for adoption of new products into existing sterilization cycles, including, but not limited to, sterilization validation, endotoxin level testing (LAL), product bioburden testing, and residual testing.
  • Generate project plans, validation master plans, test protocols, and reports for sterilization validation.
  • Coordinate microbiological testing of validation samples with in-house and outside laboratories.
  • Work with new product development teams on establishing sterilization strategies for steam, radiation, and ethylene oxide sterilization.
  • Support cycle development activities for sterilization processes, 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.
  • Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO.
  • Support clean room monitoring and validation activities, including, but not limited to, microbial, particulate, and pressure differential testing.
  • Manage sample inventories for real time and accelerated aging studies to support Design Quality/R&D projects.
  • Provide expertise and write-ups to support NCRs and/or CAPAs.
  • Perform other duties as assigned.

    1. Bachelor’s degree in related field or equivalent.
    2. A minimum of four (4) years of related professional experience.
    3. Understanding 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.
    4. Working knowledge of various sterilization processes including steam, heat, radiation, ethylene oxide.
    5. Experience working with biological indicators (BI’s) and preparing validation samples.
    6. Technical writing abilities, including test protocols, reports, and justification documents.
    7. Ability to program and extract data from temperature/pressure data loggers.
    8. Ability to operate sterilization equipment.
    9. Experience working with laboratory testing vendors.
    10. Strong written and verbal communication skills.
    11. Ability to manage multiple projects simultaneously, stay organized, effectively manage obstacles, and drive projects to completion.
    12. Ability to actively collaborate with other departments.
    13. Proficient computer skills including MS Word, Excel, Teams, Outlook, and data logging software.
    Desired Qualifications
    1. Advanced degree in a related field of study.
    2. Skills in generating write-ups to support NCRs and/or CAPAs.
    3. Advanced degree in related discipline.
    4. Certifications in related discipline (ex. CISS).