• Job Description

  Req#: 32439587128

  Have you ever wanted to make a difference?

  At Abbott, you will play a crucial role in helping people live more fully at all stages of their lives. Abbott is a global healthcare leader with a portfolio of life-changing technologies spanning diagnostics, medical devices, nutritional products, and branded generic medicines. Our 113,000 colleagues impact lives in over 160 countries daily.

  Abbott Ireland

  In Ireland, Abbott employs around 6,000 people across ten sites, including manufacturing facilities in Clonmel, Cootehill, Donegal, Longford, and Sligo, as well as commercial, support operations, and shared services in Dublin and Galway. We have been making a difference in Irish lives since 1946.

  Diabetes Care Kilkenny

  Our new manufacturing facility in Kilkenny, opening in 2024, will focus on Abbott's Diabetes Care products, including the FreeStyle Libre 3, a system providing real-time glucose readings with a small, wearable sensor that offers 14-day accuracy and optional alarms. This enables people with diabetes to live better lives.

  At Abbott Kilkenny, you can shape your career while helping shape the future of healthcare.

  This is how you can make a difference at Abbott:

  This role involves creating and implementing the Abbott Division validation program, maintaining validation documentation for systems and processes, and ensuring validation activities comply with standards in Abbott's Quality Systems Manual. You may also travel to vendor locations in Europe or the US for training. Prior experience in software project implementation from greenfield stage is preferred.

  Responsibilities

  1. The validation and operational management of computerized systems.
  2. The creation and review of validation documentation in line with regulatory requirements and policies.
  3. Creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
  4. Maintaining the quality and compliance status of procedures and work instructions.
  5. Presenting status updates, report metrics, identifying trends, potential issues, and improvement initiatives.

  Qualifications and Experience

  • Relevant third-level qualification in IT, Engineering, Manufacturing, or Science.
  • 2-3 years of experience in software validation within the medical devices industry.
  • Hands-on experience in Software quality assurance, SDLC, and testing methodologies.
  • Experience in Software Change management and validation deliverables review.
  • Proven expertise in authoring and reviewing 21 CFR Part 11 and data integrity assessments.
  • Strong understanding of regulatory standards in the medical device industry.
  • Proficiency with automated testing tools and frameworks.
  • Excellent problem-solving and attention to detail.
  • Ability to collaborate across teams and communicate effectively.
  • Experience with risk management strategies.

  What we Offer

  Competitive compensation, including benefits such as:

  • Family health insurance,
  • Excellent pension scheme,
  • Life assurance,
  • Career development opportunities,
  • State-of-the-art facility,
  • Growing business with additional benefits.

  Connect with us at www.abbott.com or on LinkedIn at Abbott LinkedIn, on Facebook at Abbott Facebook, and on Twitter @AbbottNews.

  Abbott is an equal opportunities employer.

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• About the company

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