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Boston Scientific Sterility Engineer II 
Malaysia, Penang 
755414391

20.09.2024

Key Responsibilities

  • Supports Sterilization validations (EO and irradiation) for Penang Site.
  • Supports Sterilization regulatory and compliance activities at Penang Site.
  • Supports Sterilization submissions to regulatory bodies.
  • Key Sterilization person at sites during external audits.
  • Key role in conducting audits of Sterilization vendors and facilities.
  • Liaise with Contract sterilization providers in addressing deviations and/or downtime.
  • Regular communication with Global Sterility Assurance Organization.
  • Compliance to internal BSC procedures and GMP practices.
  • Good knowledge of MDD and FDA requirements.
  • Good knowledge of EO E-Beam and Gamma Sterilization.
  • Knowledge of Sterilization and Quality System Standards.
  • Plans and coordinates sterilization evaluations requests from Penang site.
  • Management and preparation of dunnage's for sterilization activities
  • Understands engineering principles theories, concepts, practices and techniques. Develops knowledge in a field to become a recognized leader or authority in sterilization and applies this knowledge in leadership roles in the company.
  • Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
  • Serves as a resource in the orientation and training of new engineers and employees. May lead a project team, determining goals and objectives for the projects. Mentors employees by sharing technical expertise and providing feedback and guidance.

Job Requirements:

  • Candidate required process at least Bachelor Degree in science/engineering.
  • At least 2 -5 years of working experience in related field.
  • Knowledge: EO/irradiation/E-Beam sterilization, cGMP, Combination Device Regulations and other Sterilization related regulations.
  • Candidate from medical industry will be preferable.