About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Our 114,000 colleagues serve people in more than 160 countries.
Abbott in Ireland
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products.
In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
Abbott Diabetes Care Kilkenny
Abbott Diabetes Care has opened a new site in Kilkenny that is at the forefront of Diabetes care with the latest technology to manufacture FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management.
Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems.
This is how you can make a difference at Abbott:
As a Validation SME, you will function as an Individual contributor or team lead to lead site Validation activities, primarily focusing on Software Validation with a secondary focus on Process and/or Equipment Qualifications.
You will work closely with various stakeholders including Systems/Controls Engineering, Process Engineering, PMO, Operations, Global Engineering and Quality.
Responsibilities:
* Define software validation strategy for specific projects in alignment 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:
* Attractive compensation package that includes competitive pay, family health insurance, excellent pension scheme, life assurance, career development, fantastic new facility, growing business plus access to many more benefits.