Senior NPI Process Validation Engineer (Penang)

Ambu A/S; George Town; On-site; MYR 67,000 - 112,000; Full time

Job summary

Ambu A/S seeks a Senior NPI Engineer (Process Validation) for our Penang hub to drive validation activities for new production lines and design changes. You will prepare protocols, execute tests, and compile detailed reports to ensure compliant processes.

The role requires collaboration with project stakeholders, troubleshooting NCRs/CAPAs, and strong English communication in a dynamic, international environment.

Qualifications

• Must have strong understanding of process validation and validation protocols.
• Experience with FDA requirements, Design Control, ISO 13485 is a plus.
• Ability to document and communicate validation results clearly.

Responsibilities

• Establish validation strategy and scope for new production line setup and design changes.
• Own process validation activities: create protocols, run tests, compile reports.
• Define process requirements for validation and test methods.

Skills

Process Validation

Technical Documentation

Cross-functional Collaboration

Problem Solving

Teamwork

Education

Engineering degree (Mechanical / Mechatronics / Manufacturing)

Job description

Ambu A/S seeks a Senior NPI Engineer (Process Validation) for our Penang hub to drive validation activities for new production lines and design changes. You will prepare protocols, execute tests, and compile detailed reports to ensure compliant processes.

The role requires collaboration with project stakeholders, troubleshooting NCRs/CAPAs, and strong English communication in a dynamic, international environment.