EO Sterilization Validation Lead ISO 11135 Expert

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

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