Senior Validation Engineer

4 weeks ago

Penang, Malaysia Ambu AS Full time

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

Manage/perform cleanroom, utilities or system validation.

To maintain validated processes via annual review of validation or revalidation, also to review/evaluate/approve changes on existing manufacturing documents that might affect 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 all types of audits such as IQA, ISO, FDA, etc.

Requirements:

Bachelor degree in Engineering Mechanical / Science or equivalent.

Have at least 2 years of related working experience, preferably Medical Device Industry.

Have strong technical and problem-solving skills to ensure optimal project execution and implementation.

Knowledgeable on effective and efficient product manufacturing processes.

Have strong communication skills, proficient in written and spoken English.

Able to work independently, be structured and systematic. Able to work in a cross-cultural team.

Understand documentation work is part of work nature.

Must have a sense of urgency and commitment to project schedules.

See it as a challenge to work in a dynamic international environment.

It will be an advantage to have relevant experience from the Medical Device industry including FDA requirements, Design Control, Process Validation and ISO 13485.

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.

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