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

Your tasks

• 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.

Requirements

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.

How to apply

For interested candidates, please send your most recent and updated resume to sallytsin@recruitexpress.com.sg

Other

Tsin Chien Yee Sally R25127272 Recruit Express Pte Ltd EA License No. 99C4599