Help people live more fully at all stages of their lives as a crucial part of Abbott, a global healthcare leader.
Abbott's portfolio spans the spectrum of healthcare with leading businesses and products in diagnostics, medical devices, nutritional products, and branded generic medicines.
We have a daily impact on the life of people in over 160 countries thanks to our 113,000 colleagues worldwide.
About Us
Abbott Ireland employs around 6,000 people across ten sites. Our operations include six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, and Sligo, as well as commercial, support operations, and shared services in Dublin and Galway.
We've been making a difference in the lives of Irish people since 1946.
New Manufacturing Facility in Kilkenny
This new facility reflects the growing demand for Abbott's global Diabetes Care products.
The centre will house world-class engineering, quality, medical device manufacturing, and science-based professionals producing life-changing technologies for people with diabetes.
You can shape your career and help shape the future of healthcare at Abbott in Kilkenny.
Job Description
Act as a Validation SME, either as an individual contributor or team lead, to lead site validation activities primarily focusing on Software Validation, with secondary focus on Process and/or Equipment Qualifications.
Work closely with various stakeholders including Systems/Controls Engineering, Process Engineering, PMO, Operations, Global Engineering, and Quality.
Main Responsibilities
* Define software validation strategy for specific projects aligned with corporate procedures.
* Draft or collaborate on software project validation pre-requisites such as validation plans, 21 CFR Part 11 assessments, software risk assessments, and requirement traceability matrices.
* Generate and execute validation protocols and associated reports for Software Validation Activities and technical reports related to equipment, products, and/or processes.
* Provide necessary documentation and support during internal and external audits.
* Offer technical support and guidance on system requirements and validation processes as required.
* Provide direction and mentoring to junior team members.
Education and Experience
* NFQ Level 7 qualification in Engineering/Science or Equivalent.
* 5 years' experience in a similar environment.
* Project management experience, ability to work to pre-agreed schedules, and report on progress to management.
* Lead investigations into validation anomalies or deviations and apply problem-solving methodologies to arrive at and implement corrective actions.
* May assist with establishing corporate validation policies.
* Strong understanding of GAMP5 and regulatory requirements.
What We Offer
An attractive compensation package that includes competitive pay, benefits such as:
* Family health insurance.
* Excellent pension scheme.
* Life assurance.
* Career Development.
* Fantastic new facility.
* Growing business plus access to many more benefits.