Validation Technician

Summary

As our business grows, we are strengthening our presence in Hong Kong by hiring a Validation Technician to support the execution of validation activities for medical devices, including automated endoscope reprocessors (AERs), endoscope storage cabinets, and other related infection prevention systems, in accordance with approved protocols and regulatory requirements.

In this role, you will play a key part in equipment installation, commissioning, and performance qualification by performing hands-on testing, data collection, and documentation.

You will work closely with sales team and service engineers to ensure validation activities are delivered efficiently, accurately, and in full compliance at Customer sites.

What You Will Do

• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities in accordance with approved validation protocols.
• Perform calibration checks, functional testing, and system performance verification to ensure equipment operates within specified parameters.
• Provide on-site technical and validation support during equipment installation, commissioning, and validation activities to ensure successful system implementation.
• Accurately collect, record, and maintain validation data, test results, and supporting documentation in compliance with internal quality systems and regulatory standards.
• Assist in the preparation, compilation, and review of validation reports, including test summaries, deviations, and supporting evidence.
• Support troubleshooting activities related to validation testing and equipment performance under guidance.
• Ensure all validation activities comply with applicable standards, including ISO, HTM, local regulatory requirements, and internal procedures.
• Maintain proper documentation control and ensure validation records are complete, accurate, and audit-ready.
• Coordinate validation schedules and timelines with Customers to support project execution.
• Collaborate cross-functionally with Service, Sales, and Quality teams to meet project timelines and Customer requirements.
• Support validation preparation activities, including test setup and readiness checks.

The Experience, Skills and Abilities Needed

• Diploma/Associate Degree in a relevant technical field preferred.
• Experience in validation, equipment qualification, or regulated environments (e.g., healthcare, laboratory, sterilization).
• Exposure to IQ/OQ/PQ, validation protocols, or technical testing/calibration is essential.
• Experience with on-site installation or commissioning is a plus.
• Proficient in MS Office with strong documentation and data accuracy skills.
• Basic working knowledge of ISO, HTM, and regulatory standards.
• Strong communication, coordination, and attention to detail; able to follow procedures and work under guidance.

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