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

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.


For interested candidates, please send your most recent and updated resume to [email protected]

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