Validation Engineer

Abbott Diabetes Care Kilkenny

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

In Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.

Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.

At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.

This is how you can make a difference at Abbott:

In this role you will be responsible for assisting with the execution of the validation activities for the ADC assembly lines and facility in Kilkenny. You will be responsible for executing on validation activities for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual. There will be a fantastic opportunity to travel with this position to Mainland Europe also.

You will be responsible for:

• Work with R&D. QA, PMO and Global Engineering functions to define and document validation strategies for new product introductions
• Complete impact assessments of proposed changes and/or new products and determine scope of validation work
• Generate, execute and/or review validation protocols and associated reports for related Process & Software Validation Activities
• Identification of improvements to manufacturing process & software and assist with implementation of same
• Ability to manage multiple responsibilities at once while adhering to project plans and timelines and report on progress to management

• Provide direction and mentoring to junior engineers as required

• Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
• Knowledge of cGMP and industry regulations

Qualifications and experience:

• Relevant third level qualification in Engineering/Manufacturing/Science is preferred.
• Minimum 2 years in the Engineering/Manufacturing/Scientific field.
• 2 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments
• Basic understanding of design controls, design transfer and validation lifecycle.
• Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations

Abbott is an equal opportunities employer.