Sterilization Engineer / Sterility Assurance Engineer | EO Validation & ISO 11135 | Changi Medical Device MNC #HYT

Employment Type: Full-Time
Location: Changi / East
Working Hours: Monday–Friday, Office Hours

Job Scope:

• Lead Ethylene Oxide (EO) sterilization validation and requalification activities
• Prepare and execute sterilization protocols, reports and documentation
• Monitor sterilization processes and microbiological testing requirements
• Investigate sterilization issues and implement CAPA
• Support risk assessments, audits and regulatory compliance
• Work with manufacturing and quality teams on process improvements

Requirements:

• Bachelor's Degree in Engineering, Microbiology, Biotechnology or related discipline
• Minimum 2 years of relevant sterilization / sterility assurance experience
• Hands-on experience with Ethylene Oxide (EO) sterilization and validation
• Knowledge of ISO 11135, ISO 13485 and FDA requirements
• Experience preparing validation protocols and technical reports
• Knowledge of bioburden testing, EO residuals or Minitab is an advantage

All qualified applicants, please click “ APPLY NOW”

Or you may send in your resume to:
Whatsapp: https://wa.me/+6597430026
Email : [email protected]

Kimmy Low Yi Ting (Kim) | CEI Registration Number: R23112122
Recruit Express Pte Ltd Company Reg. No. 199601303W | EA LICENCE Number: 99C4599