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.
Abbott IrelandIn Ireland, Abbott employs around 6,000 people across ten 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.Diabetes Care KilkennyOur new manufacturing facility in Kilkenny, 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 that enable 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:
Act as a Validation SME to 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.
Works closely with various stakeholders including, but not limited to:
Systems/Controls Engineering, Process Engineering, PMO, Operations, Global Engineering and Quality.
Define software validation strategy for specific projects in alignment with corporate procedures andDraft or collaborate on software project validation pre-requisites such as validation plans, 21 CFR Part 11 assessments, software risk assessments and requirement traceability matrices,Generates and executes 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 requiredProvide direction and mentoring to junior team membersEducation and ExperienceNFQ Level 7 Qualification in Engineering/Science or Equivalent5 Years experience in a similar environmentProject 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 requirementsAt 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.
Abbott IrelandIn Ireland, Abbott employs around 6,000 people across ten 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.Diabetes Care KilkennyOur new manufacturing facility in Kilkenny, 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 that enable 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:
As a CAPA Engineer you will facilitate and execute the CAPA process.
You will also support continuous improvement and effective maintenance of the QMS.
Ensure the use of appropriate risk management tools to prioritise activities.
Key ResponsibilitiesParticipate in the completion of CAPA projects, ensuring compliance, and quality of records.
Collaborate with cross-functional teams using various methodologies (e.g.
Six Sigma root cause analysis/problem solving skills).Independently investigate, gathers data, and perform preliminary analysis.
Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
Identify trends potential issues, improvement initiatives.
Ensure on-time completion of Quality Assurance engineering deliverables.
Support team in the delivery and oversight of CAPA training program.
Identify projects to enhance and promote effectiveness, and efficiency of the quality system and product quality.
Support Operations to make Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring and packaging.
Provide support and subject matter expertise during audits and inspections.
Qualification and ExperienceMinimum Level 7 NFQ qualification or equivalent in a relevant discipline.
Min of 4 years experience in Engineering/Manufacturing/Scientific environment.
Previous CAPA and/or quality assurance/engineering experience.
Ability to demonstrated use of quality tools/methodologies.
Prior medical device experience preferred.
Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.Good communication and interpersonal skills.
Previous project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
Advanced computer skills, including statistical/data analysis and report writing SkillsWhat we OfferAttractive compensation package that includes competitive pay, as well as benefits such asFamily health insurance,Excellent pension schemeLife assuranceCareer DevelopmentFantastic new facilityGrowing business plus access to many more benefits.
Abbott is an equal opportunities employer.