Senior NPI Engineer (Process Validation) I

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

Senior NPI Engineer (Process Validation) I

City: Penang Country/Region: Malaysia State: Business Area: R&D Department: New Product Introduction Employment Type: Full-time Req ID: 10676

Ambu A/S is currently looking for an NPI Engineer for our Process Validation team to be based in Ambu Global Hub, in Penang, Malaysia.

Key responsibilities

• Participate in establishing validation strategy and scope for new production line set up and design changes.
• Accountable for process validation activities which includes creating protocols, executing tests and compiling reports.
• Support activities on defining process requirements for validation, plus the test methods.
• Collaborate with project stakeholders to ensure process validation are carried out effectively and successfully to meet project objectives.
• Resolve quality issues related to new and existing products, including handle NCRs and CAPAs.
• Execute / support assigned tasks including provide technical or engineering support plus problem solving.

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• A degree in Engineering Mechanical / Mechatronics / Manufacturing Engineering or equivalent.
• Fresh graduates are also welcome to apply. However, working experience in Medical Device or Healthcare Industry will be given priority.
• For experienced candidates, technical and documentation skills are good to have to ensure optimal project execution and implementation. It will be an advantage to have relevant experience in FDA requirements, Design Control, Process Validation and ISO 13485.
• Knowledge in manufacturing processes, equipment, tests and process validation are added advantage.
• Good communication skills in English, written and spoken.
• Able to work with minimal supervision, be structured and systematic. Able to work in a cross-cultural team.
• Understands urgency and commitment to project schedules.
• Able to work in a dynamic international environment.

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

• We offer great opportunities for personal development.
• Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

For more information, please visit ambu.com or follow us on LinkedIn .