Validation Engineer
Validation Engineer
Location: Abbott Diabetes Care, Kilkenny, Ireland
About Abbott
Abbott is a global healthcare leader, committed to helping people live more fully at all stages of life. With a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines, Abbott serves over 160 countries and employs 114,000+ people worldwide.
Abbott in Ireland
Operating since 1946, Abbott employs around 6,000 people across ten sites in Ireland, including Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford, and Sligo.
Abbott Diabetes Care Kilkenny
Our Kilkenny site is a state-of-the-art facility focused on manufacturing FreeStyle blood glucose test strips and sensors, supporting leading diabetes management systems such as FreeStyle Precision, FreeStyle Lite, and FreeStyle Libre.
Main Purpose of the Role
As a Validation Engineer, you will act as a Subject Matter Expert (SME) within the Operations department, supporting site-wide validation activities with a primary focus on Process and Equipment Qualifications. You will ensure the delivery of safe, effective products that meet customer needs while maintaining regulatory compliance.
Key Responsibilities- Develop, execute, and review validation protocols and reports for process and software validation activities.
- Identify and implement improvements in manufacturing processes and software systems.
- Support investigations into non-conformances related to manufacturing processes and software.
- Collaborate with cross-functional teams including Validation, PMO, Operations, Global Engineering, and Quality.
- Apply structured problem-solving techniques (e.g., 6M, Ishikawa, DMAIC) to identify root causes of component-related issues.
- Conduct empirical testing, data analysis, and report findings to support continuous improvement.
- Support R&D trials and feedback loops for material changes.
- Monitor and drive performance improvements of materials/components.
- Evaluate proposed changes and alternative designs for components.
- Assist in resolving Quality Incidents and CAPAs.
- Apply LEAN methodologies to drive operational excellence.
- Maintain visual dashboards and contribute to site KPI reporting.
- Provide technical support to engineering teams.
- Ensure compliance with cGMP, industry regulations, and Abbott’s Quality Policy and Procedures.
- Education: NFQ Level 7 qualification (minimum) in a relevant engineering or scientific discipline.
- Experience: Minimum 2 years of related work experience (Validation Engineer role); 5+ years for materials/component engineering responsibilities.
- Preferred Background:
- Experience in a GxP-compliant manufacturing environment.
- Hands-on experience with high-volume automation lines.
- Familiarity with electrical, moulded, and mechanical components.
- Proficiency in Six Sigma and structured problem-solving tools.
- Competitive salary and benefits package.
- Family health insurance.
- Excellent pension scheme and life assurance.
- Career development opportunities.
- Access to a modern, innovative facility.
- A growing business with a strong global presence.
Connect With Us
Visit www.abbott.com or follow us on LinkedIn, Facebook, Instagram, X, and YouTube.
Abbott is an equal opportunities employer.