Software Validation Engineer

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What you need to know 

You will work as a Software Validation Engineer for our client, an established Medical Device company in the Southeast.

This is a permanent position.

Your new job 

Key duties & responsibilities: 

  • Responsible for preparing computer software validation protocols, test scripts and reports.
  • Responsible for evaluating changes to validated/qualified Systems
  • Responsible for software deviations and non-conformances
  • Ensure review of all software related GMP critical documents
  • Partake in software corrective action process  and CAPA plans.
  • Review of pre-delivery or vendor-supplied information with regards to suitability to proceed with validation activities.
  • Travel to vendor locations for project reviews will be required.
  • Provide technical expertise in the validation of new technologies to ensure they meet the Safety, Quality and Operational requirements.
  • Lead and participate in risk management activities e.g. FMEAs.

What are we looking for?

  • Qualified to degree level in Engineering or computing discipline
  • 3-5 years’ experience in a computer system validations role.
  • Working knowledge of statistical analysis and machine vision fundamentals would be a plus.
  • Experience with vendor equipment builds, process automation, machine vision systems and medical products desirable.
  • Knowledge of latest regulatory/industry standard approaches to Data Integrity.

Apply for this job now by sending your CV to John.

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Recruitment Consultant: John O' Donnell

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