Sterilization Process Specialist

hace 4 días


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

**Job Summary:**

The Sterilization and Environmental Control Manager supervises the activities related to the control of the sterilization process of medical products, environmental control of clean rooms, and semi-controlled rooms. This position requires strong leadership skills to ensure compliance with procedures, standards, and specifications.

Main Responsibilities:

  • Supervise a team in the environmental control and sterilization area, ensuring compliance with the Quality System and international standards.
  • Promote continuous improvement in the plant by applying environmental assessment techniques and maintaining the Quality System.
  • 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.
  • Evaluate the root cause of sterilization and environmental control problems and provide support to departmental teams.
  • Ensure control and maintenance of compliance with biological load verification programs and dose audits.
  • Supervise sample manufacturing coordination for validations and revalidations, shipment of samples for sterility tests, and dose audits.

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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