Sterilization Engineer II: EO Compliance & Validation

Medtronic plc; Singapore; On-site; SGD 70,000 - 90,000; Full time

Benefits offered by this job

Flexible benefits package

Competitive salary

Short-term incentive plan

Job summary

A leading global healthcare technology company in Singapore seeks a Sterilization Engineer II to oversee sterilization processes, ensuring compliance with FDA and ISO standards. This role involves validating sterilization procedures, conducting technical training, and improving sterilization efficiency. Candidates should possess a Bachelor’s degree in engineering and relevant experience in the medical device or pharmaceutical industry, particularly in Sterility Assurance.

Qualifications

• Minimum of 2 years of experience in medical device or pharmaceutical industry, preferably within Sterility Assurance.
• Experience and knowledge of applicable standards and regulations (e.g., ISO 11135, ISO 13485, FDA, PMDA).
• Direct experience with EO sterilization equipment, process controls, and change management.

Responsibilities

• Ensure sterilization processes comply with specifications and FDA regulations.
• Create and release documents for sterilization processes, validation protocols, and procedural updates.
• Provide technical support to manufacturing operations including root cause analysis.

Skills

Attention to detail

Problem-solving skills

Team collaboration

Project management

Education

Bachelor’s degree in engineering (Microbiology, Biotechnology, etc.)

Relevant certifications in sterilization or quality systems

Tools

Minitab

Word processing software

Spreadsheet software

Job description

A leading global healthcare technology company in Singapore seeks a Sterilization Engineer II to oversee sterilization processes, ensuring compliance with FDA and ISO standards. This role involves validating sterilization procedures, conducting technical training, and improving sterilization efficiency. Candidates should possess a Bachelor’s degree in engineering and relevant experience in the medical device or pharmaceutical industry, particularly in Sterility Assurance.