Boston Scientific Sterility Engineer II 

Malaysia, Penang 

755414391

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.