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

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a dedicated sterilization engineer to lead EO sterilization validation and requalification activities at our Changi site. You will prepare and execute sterilization protocols, monitor processes, investigate issues, and support CAPA, risk assessments, audits and regulatory compliance with cross-functional teams in manufacturing and quality.

The role requires hands-on EO expertise and collaboration across quality systems to ensure compliance with ISO 11135, ISO

Qualifications

• Bachelor's degree in Engineering, Microbiology, Biotechnology or related discipline.
• Hands-on EO sterilization and validation experience.
• Knowledge of ISO 11135, ISO 13485 and FDA requirements.
• Experience preparing validation protocols and technical reports.
• Knowledge of bioburden testing, EO residuals is advantageous.

Responsibilities

• Lead 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.
• Collaborate with manufacturing and quality teams on process improvements.

Skills

EO sterilization

Sterilization validation

Documentation

CAPA investigation

Regulatory compliance

Education

Bachelor's degree in Engineering or related field

Tools

Minitab

Job description

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