Ambu A/S is currently looking for a Validation Engineer to be based in Penang, Malaysia.  

This position is reporting to Manager of Project Management & Validation. In this role, you will have the opportunity to involve in various types of validations such as process validation, process software validation, test method validation, cleanroom validation, utilities validation and system validations. This position is perfect for someone who thrives on precision, problem-solving, and making a measurable difference. 

Key responsibilities 

Your main responsibilities will include: 

• Manage and perform process validation activities which includes capacity expansion, line & equipment transfer, process improvement, and local equipment relocation. 

• Manage and perform cleanroom, utilities or system validation. 

• Maintain validated processes via annual review of validation or revalidation, also to review, evaluate & approve changes on existing manufacturing documents that affects validity of processes such as work instructions, etc. 

• Resolve quality issues related to existing validated processes, handle NCRs and CAPAs, and provide technical or validation support plus problem solving.  

• Support audits activities such as IQA, ISO, FDA, etc. 

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: 

• Minimum education of Bachelor’s Degree in Mechanical or other engineering disciplines or science disciplines. 

• Minimum 2 years of working experience. Experience in medical device industry will be given priority. 

• Proven technical and problem-solving skills to ensure optimal project execution and implementation. 

• Knowledge in medical industry documentation will be an added advantage. 

• Experience in FDA requirements, Design Control, Process Validation and ISO 13485 will be an added advantage. 

• Good communication to manage different level of stakeholders. Proficient in English.  

• Good time management skills.  

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.