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 meet the growing demand for Abbott's global Diabetes Care products. It will be a centre for engineering, quality, medical device manufacturing, and other science-based professionals producing life-changing technologies, including the FreeStyle Libre 3, a system delivering real-time glucose readings with a small, thin wearable sensor providing 14-day accuracy and optional alarms to smartphones. This enables people with diabetes to live their best 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 Abbo
This role involves creating and implementing the Abbott Division validation program, maintaining validation documentation for systems and processes under design control, and ensuring validation activities comply with Abbott's Quality Systems Manual. You may also travel to vendor locations in Europe or the US for training. Previous experience in software project implementation from greenfield stages is preferred.
Responsibilities
* Validation and operational management of computerized systems.
* Creation and review of validation documentation per regulatory requirements and divisional policies.
* Creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
* Maintaining quality and compliance of procedures and work instructions.
* Presenting status reports, metrics, trend analysis, and improvement initiatives.
Qualifications and Experience
* Relevant third-level qualification in IT, Engineering, Manufacturing, or Science preferred.
* 2-3 years of experience in software validation within the medical devices industry.
* Experience conducting Cybersecurity assessments.
* Experience working in a 21 CFR 820 and/or ISO 13485 regulated industry; pharmaceutical validation experience is also considered.
What we Offer
Attractive compensation package including competitive pay and benefits such as:
* Family health insurance
* Excellent pension scheme
* Life assurance
* Career development opportunities
* State-of-the-art new facility
* Growing business with additional benefits
Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
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