Social network you want to login/join with:
Join Abbott and 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 diverse portfolio that includes diagnostics, medical devices, nutritional products, and branded generic medicines. Our 113,000 colleagues impact lives in over 160 countries daily.
In Ireland, Abbott employs around 6,000 people across ten sites, including manufacturing facilities in Clonmel, Cootehill, Donegal, Longford, and Sligo, along with commercial and support operations 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 Diabetes Care products. It will be a hub for engineering, quality, and medical device manufacturing, producing innovative technologies like the FreeStyle Libre 3—a system that provides real-time glucose readings and optional alarms directly to smartphones, helping people with diabetes live better lives.
At Abbott Kilkenny, you can shape your career while helping shape the future of healthcare.
How You Can Make a Difference
This role involves creating and implementing the Abbott Division validation program, maintaining validation documentation for new and existing systems, and ensuring validation activities comply with the company's Quality Systems Manual. Travel to vendor locations in Europe or the US for training may be required. Previous experience in software projects from greenfield stages is desirable.
Responsibilities
* Validation and operational management of computerized systems.
* Creating and reviewing validation documentation per regulatory requirements and policies.
* Developing Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
* Maintaining procedures and work instructions to ensure quality and compliance.
* Presenting status reports, 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.
* Experience in cybersecurity assessments.
* Knowledge of working in a 21 CFR 820 and/or ISO 13485 regulated environment; pharmaceutical validation experience is a plus.
What We Offer
* An attractive compensation package including competitive pay and benefits.
* Family health insurance, life assurance, and other benefits.
* A state-of-the-art new facility.
* Growing business with additional perks.
Abbott is an equal opportunity employer.
#J-18808-Ljbffr