NPI Process Validation Engineer I – Impact & Growth

Ambu; Penang; On-site; MYR 60,000 - 120,000; Full time

Job summary

Ambu A/S invites applications for an NPI Engineer in the Process Validation team based at Ambu Global Hub, Penang, Malaysia.

You will help establish validation strategies for new production lines, create and execute validation protocols, tests and reports, and collaborate with stakeholders to ensure successful validations. Fresh graduates are welcome; prior medical device exposure is advantageous.

Qualifications

• Bachelor's degree in Mechanical, Mechatronics or Manufacturing Engineering.
• Fresh graduates welcome; medical device experience preferred.
• Experience with FDA requirements, Design Control and ISO 13485 is a plus.
• Knowledge of manufacturing processes, equipment, tests and validation.
• Strong English communication; able to work with minimal supervision and in cross‑cultural teams.
• Ability to operate in a fast‑paced, dynamic international environment.

Responsibilities

• Participate in establishing validation strategy and scope for new production line setup and design changes.
• Accountable for process validation activities including protocols, tests and reports.
• Support defining process requirements for validation and test methods.
• Collaborate with project stakeholders to ensure validations meet objectives.
• Resolve quality issues related to NCRs and CAPAs for new and existing products.
• Execute or support tasks providing technical engineering support and problem solving.

Skills

Engineering degree

Fresh grads ok

Medical device exp

FDA knowledge

Design Control

Process Validation

ISO 13485

Manufacturing knowledge

English proficiency

Education

Bachelor in Mechanical/Mechatronics/Manufacturing Eng

Job description

Ambu A/S invites applications for an NPI Engineer in the Process Validation team based at Ambu Global Hub, Penang, Malaysia.

You will help establish validation strategies for new production lines, create and execute validation protocols, tests and reports, and collaborate with stakeholders to ensure successful validations. Fresh graduates are welcome; prior medical device exposure is advantageous.