Lead EO Sterilization Validation Engineer

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

Job summary

Recruit Express Pte Ltd seeks a Sterility Assurance professional to lead EO sterilization validation and requalification activities in a regulated manufacturing setting in Singapore. You will develop and approve validation protocols, reports, and routine sterilization release documentation, and evaluate product and packaging to define processing parameters.

You will implement process controls, microbiological monitoring programs, and support CAPA investigations.

Qualifications

• Bachelor's degree with 2+ years in Sterility Assurance, sterilization engineering, quality engineering, or related manufacturing.
• Experience with EO sterilization processes, validation, process controls, and change management.
• Knowledge of ISO 11135, ISO 13485, FDA requirements and sterilization standards.
• Experience authoring validation docs, reports, and QMS records.

Responsibilities

• Lead EO sterilization validation and requalification activities per regulatory and quality requirements.
• Develop, execute, and approve validation protocols, reports, and sterilization release documentation.
• Evaluate product and packaging to set sterilization parameters and performance requirements.
• Implement and maintain sterilization process controls and microbiological monitoring programs.
• Support investigations, root cause analysis, and CAPA related to sterilization processes.
• Collaborate with global teams to standardize sterilization strategies and best practices.
• Maintain sterilization risk assessments (FMEAs) and support audit readiness.
• Provide technical support to manufacturing including equipment qualification, calibration oversight, and process improvements.

Skills

Sterility Assurance

Validation engineering

Quality engineering

Regulatory compliance

Education

Bachelor's degree

Job description

Recruit Express Pte Ltd seeks a Sterility Assurance professional to lead EO sterilization validation and requalification activities in a regulated manufacturing setting in Singapore. You will develop and approve validation protocols, reports, and routine sterilization release documentation, and evaluate product and packaging to define processing parameters.

You will implement process controls, microbiological monitoring programs, and support CAPA investigations.