Computer Systems Validation Engineer - Abbott Ireland Diabetes Care
  • Kilkenny, Leinster, Ireland
  • via BeBee.com
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Job Description

Join a global healthcare leader as a Validation Engineer and play a crucial role in shaping the future of healthcare.

Abbott is a global healthcare leader with a portfolio of life-changing technologies spanning diagnostics, medical devices, nutritional products, and branded generic medicines.

As a Validation Engineer, you will be responsible for creating and implementing the Abbott Division validation program, ensuring validation activities are implemented for systems as per requirements and standards.

You will work on creating and maintaining validation documentation for new and existing systems and processes, and ensure compliance with regulatory requirements and divisional policies.

Key responsibilities include:

  • Validation and operational management of computerized systems
  • Creation and review of validation documentation in accordance with regulatory requirements and divisional policies
  • Software Compliance assessments such as 21 CFR Part 11 and Data Integrity
  • Maintaining the quality and compliance status of associated Procedures, work instructions
  • Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives

Requirements:

  • Relevant third-level Engineering/Manufacturing/Science qualification
  • 2-3 years working knowledge of software validation in med devices industry
  • Experience carrying out Cyber security assessments
  • Experience working in a 21CFR820 and/or ISO13485 regulated industry

What we offer:

  • Attractive compensation package
  • Competitive pay
  • Family health insurance
  • Excellent pension scheme
  • Life assurance
  • Career development opportunities
  • Fantastic new facility
  • Growing business

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