Validation Engineer

Abbott

Kilkenny

On-site

EUR 60,000 - 80,000

Full time

5 days ago

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Benefits offered by this job

Family health insurance

Excellent pension scheme

Life assurance

Career Development

Fantastic new facility

Growing business

Job summary

Abbott Diabetes Care Kilkenny is seeking a Validation Engineer to lead qualification activities ensuring compliant, high-quality manufacturing. You will drive process validation, equipment qualification, and related validation efforts across sustaining projects in a regulated environment.

The role requires a NFQ Level 7 degree and 2+ years of experience, with emphasis on cGMP practices and cross-functional collaboration with R&D, QA, and Global Engineering teams.

Qualifications

NFQ Level 7 qualification in Engineering/Science/Manufacturing or equivalent.
Minimum 2 years of relevant industry experience.
Experience in regulated manufacturing environments preferred.
Knowledge of validation methodologies and cGMP requirements.

Responsibilities

Lead Process Validation and Equipment Qualification activities for sustaining projects.
Develop validation strategies for new product introductions with R&D, QA, PMO and Global Engineering.
Assess impact of proposed process changes to determine validation requirements.
Generate, execute, review and approve validation protocols and reports.
Support process and software validation across the site.
Identify opportunities to improve manufacturing processes and software systems.
Drive compliance and operational excellence through validation practices.
Manage multiple projects and timelines; communicate progress to stakeholders.
Mentor junior engineering team members and ensure regulatory compliance.

Skills

Process Validation

Equipment Qualification

cGMP knowledge

Regulatory compliance

Cross-functional collaboration

Mentoring junior engineers

Education

NFQ Level 7 qualification in Engineering/Science/Manufacturing

Job description

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.

Please note any offer of employment for this position isconditional upon the successful completionof a pre-employment medical examination, including drug and alcohol screening, conducted by a medical

practitioner designated by the Company

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.

About the Role

This role plays a critical part in ensuring compliance, product quality, and operational excellence within a regulated manufacturing environment. The Validation Engineer will lead qualification activities for sustaining projects while collaborating with cross-functional teams to support new product introductions and process improvements. The position will focus on Process Validation, Equipment Qualification, and associated validation activities to ensure manufacturing processes remain compliant, efficient, and capable of delivering high-quality products.

Key Responsibilities

Lead Process Validation and Equipment Qualification activities for sustaining projects.
Develop and implement validation strategies for new product introductions in collaboration with R&D, Quality Assurance, PMO, and Global Engineering teams.
Complete impact assessments for proposed process changes and new products to determine validation requirements.
Generate, execute, review, and approve validation protocols and validation reports.
Support Process and Software Validation activities across the manufacturing site.
Identify opportunities to improve manufacturing processes and software systems.
Support the implementation and validation of process improvements.
Drive compliance and operational excellence through effective validation practices.
Manage multiple projects and priorities while adhering to established timelines.
Communicate project progress and validation status updates to management and key stakeholders.
Collaborate closely with cross-functional teams to ensure successful project delivery.
Provide guidance and mentoring to junior engineering team members.
Ensure compliance with corporate policies, divisional procedures, and regulatory requirements.
Maintain a strong understanding of current cGMP requirements and industry regulations.

Education & Experience:

NFQ Level 7 qualification (or equivalent) in Engineering, Science, Manufacturing, or a related technical discipline.
Minimum of 2 years' relevant industry experience.
Experience in a regulated manufacturing environment is preferred.
Experience within high-volume manufacturing operations would be advantageous.
Knowledge of validation methodologies, qualification activities, and cGMP requirements.

What we Offer

Attractive compensation package that includes competitive pay, as well as benefits such as