Senior NPI Engineer (Process Validation) I

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

Your Main Responsibilities Will Include

• 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:

Skills

• 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.