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Sterilization Technician

  • Full Time, onsite
  • Pentamaster Corporation Berhad (Official)
  • Simpang Ampat, Malaysia
Salary undisclosed

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JOB OBJECTIVE

Responsible for the overall Ethylene Oxide Sterilization Plant, equipment, process qualification, quality, yield and sterilization manufacturing operation and improvement.

MAIN RESPONSIBILITIES AND DUTIES

  • Responsible to develop, configure, and optimize sterilization manufacturing processes.
  • Responsible to develop best practices, routines, and innovative solutions to improve production rates and quality of output.
  • Responsible to develop and maintain process documentation and operating instructions for the sterilization processes.
  • Responsible for risk management evaluation e.g., FMEA
  • Responsible for the qualifications for equipment and process (DQ/SAT/IQ/OQ/PQ)
  • Ensure all the written procedures and working instructions for assembly and packaging are straightly observed, and all documents must be up to date.
  • Responsible to perform necessary planned maintenance for the equipment.
  • Ensure workplace are clean and safe to work all the time.
  • Perform any other relevant responsibility that may be assigned occasionally as required by management or immediate superior.

JOB REQUIREMENTS

Qualifications

Degree in Engineering,

Experience

Minimum 1 – 3 years in process engineering, and medical manufacturing environment for ethylene oxide sterilization.

Familiar with GMP, ISO 13485 and ISO 11135.

Skill

Good verbal and written communication skill.

Able to work independent.

Must be a good team player and possess good collaboration skills.

Excellent analytical and problem-solving skills.