At Abbott, you will play a crucial role in helping people live more fully at all stages of their lives.
We are a global healthcare leader with a portfolio of life-changing technologies spanning diagnostics, medical devices, nutritional products, and branded generic medicines.
In Ireland, we employ approximately 6,000 people across ten sites, including six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, and Sligo.
Diabetes Care Kilkenny
This new facility in Kilkenny reflects the growing demand for our global Diabetes Care products.
Here, you can shape your career as you help shape the future of healthcare by contributing to the production of life-changing technologies that enable people with diabetes to live their best lives.
About this Role
You will act as a Validation Subject Matter Expert (SME), leading site validation activities, primarily focusing on Software Validation, with a secondary focus on Process and/or Equipment Qualifications.
Collaborate closely with various stakeholders, including Systems/Controls Engineering, Process Engineering, PMO, Operations, Global Engineering, and Quality.
* 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 guidance on system requirements and validation processes as required.
Provide direction and mentoring to junior team members.
Requirements
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.
What We Offer
A competitive compensation package, including:
* Family health insurance
* Life assurance
* Fantastic new facility
* Growing business plus access to many more benefits.
Abbott is an equal opportunities employer.