[Medical Device MNC] Sterlization Engineer - UP$7000 (Changi, office Hours) #HCY

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

Primary Responsibilities

• Lead sterilization validation and requalification activities for Ethylene Oxide (EO) processes in accordance with applicable regulatory and quality requirements.


• Develop, execute, and approve validation protocols, reports, and routine sterilization release documentation.


• Evaluate product and packaging characteristics to establish sterilization processing parameters and performance requirements.


• Implement and maintain sterilization process controls and microbiological monitoring programs.


• Support investigations, root cause analysis, and corrective and preventive action (CAPA) activities related to sterilization processes.


• Collaborate with global cross-functional teams to standardize sterilization strategies, protocols, and best practices.


• Maintain sterilization risk assessments, including Failure Mode and Effects Analyses (FMEAs), and support audit readiness activities.


• Provide technical support to manufacturing operations, including equipment qualification, calibration oversight, and process improvements.

Required Qualifications

• Bachelor's degree with 2+ years of experience in Sterility Assurance, sterilization engineering, quality engineering, or related medical device or pharmaceutical manufacturing experience.


• Experience with Ethylene Oxide (EO) sterilization processes, validation, process controls, and change management.


• Knowledge of ISO 11135, ISO 13485, U.S. Food and Drug Administration (FDA) requirements, and other applicable sterilization regulations and standards.


• Experience authoring and executing validation documentation, technical reports, and quality system records within a Quality Management System (QMS).

Preferred Qualifications

• Degree in Engineering, Microbiology, Biotechnology, or a related technical discipline.


• Experience with parametric release processing.