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Jobs or company...

Validation Engineer

Salary undisclosed

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JobStreet
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Responsibilities:

  • 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 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 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.

What can Ambu offer you?

Ambu is experiencing a very positive and exciting development. We are a dynamic and international workplace with skilled colleagues who emphasize freedom with responsibility and to have a good working environment.

Ambu’s ambitious growth objectives means that there is a natural focus on the ongoing development of your professional and personal skills that will help to ensure our continued success.

We offer a wide range of professional, social and economic benefits, in addition to the exciting challenges of the job, which adds to your job satisfaction.

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