A global leader in the medical device industry is seeking a highly skilled Senior Cleanline or Sterilization Engineer to join our team. This role is critical in ensuring the safety, compliance, and integrity of life-saving medical products through advanced cleaning and sterilization processes.
Based in Malaysia.
The Role
In this position, you will take full ownership of the development, optimization, and validation of cleaning and sterilization lifecycles. You will act as a technical expert, ensuring all processes meet rigorous international regulatory standards such as FDA, ISO 13485, and NMPA.
Key Responsibilities
- Process Development & Optimization: Lead the development and continuous monitoring of cleaning processes, including passivation and chemical efficiency.
- Equipment Validation: Manage the entire lifecycle of cleaning machines and purified water systems, including IQ/OQ/PQ to maintain a validated state.
- Sterilization Management: Lead the validation and daily monitoring of sterilization processes such as Ethylene Oxide (EO) and Radiation.
- Packaging Integrity: Validate finished product packaging processes, including seal integrity testing and transportation simulations.
- Compatibility Studies: Evaluate the impact of sterilization on implant material performance and packaging system functionality.
- Consumable Management: Oversight of detergents, filter bags, and ultrasonic baskets, including performance monitoring and replacement cycles.
- Quality & Compliance: Lead deviation investigations, root cause analysis (RCA), and maintain technical documentation and SOPs to support audits.
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