Clean Room Compliance Expert

hace 4 días

Ciudad Guayana, Estado Bolívar, Venezuela Jabil Circuit A tiempo completo

**Job Description:**

We are seeking a highly experienced Sterilization and Environmental Control Manager to join our team. The ideal candidate will have a strong background in science, chemistry, or engineering and experience in sterilization and environmental control.

Main Responsibilities:

  • Oversee the sterilization process, environmental control of clean rooms, and semi-controlled rooms.
  • Ensure compliance with procedures, standards, and specifications.
  • Maintain all ethylene oxide chambers revalidated and follow up with customers for revalidation requirements.
  • Develop and execute validation strategies for new products sterilized by ethylene oxide or radiation.

Requirements:

  • Professional degree in science, chemistry, microbiology, or engineering.
  • Knowledge of sterilization and environmental standards (ANSI AAMI ISO 11135, ANSI AAMI ISO 11137, and ISO 14644).
  • Current knowledge of QSR-21 CFR Part 820 and ISO 13485 Quality System standards.
  • Internal auditor or quality engineer certification preferred.
  • Certified Six Sigma Green Belt or above preferred.

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