About the role

AI summarised

The Sterilization Engineer II is responsible for ensuring that sterilization processes, particularly Ethylene Oxide (EO), comply with stringent regulatory and internal quality system requirements, including FDA, PMDA, ISO 11135, and ISO 13485 standards. This role drives sterilization validations, process improvements, and global standardization initiatives within a fast-paced medical device environment.

MedTechOnsite

Key Responsibilities

Ensure sterilization processes, including release and validation, comply with specifications and all relevant FDA regulations and ISO standards (ISO 11135, ISO 13485).
Validate and implement sterilization processes alongside microbiological controls.
Navigate the QMS to create and release essential documents such as validation protocols/reports, routine release documentation, and procedural updates.
Create and execute comprehensive validation documentation covering product scope, resistance hierarchy, and process equivalency.
Collaborate with global teams to align strategy, planning, and execution of sterilization processes, protocols, and best practices.
Oversee the requalification, maintenance, and calibration of sterilization equipment to ensure optimal performance.
Provide technical support to manufacturing operations, including root cause analysis and CAPA implementation.
Drive continuous improvement initiatives related to sterilization effectiveness, efficiency, and compliance.

Requirements

Bachelor’s degree in Engineering (Microbiology, Biotechnology, or equivalent).
Minimum of 2 years' experience in medical device or pharmaceutical industry, preferably in Sterility Assurance.
Direct experience with EO sterilization equipment, process controls & change management.
In-depth knowledge of applicable standards and regulations (ISO 11135, ISO 13485, FDA, PMDA).
Proficiency in written and spoken English with strong communication skills.
Computer proficiency using Word, Spreadsheet, and Minitab.