Qa Validation Engineer

Overview

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QA Validation Engineer

role at

AbbVie

We are now hiring a QA Validation Engineer on our Ballytivnan Medical Device site in Sligo.

In this role, you will join AbbVie's Quality team, supporting the development and maintenance of the site validation program and ensuring compliance with AbbVie, FDA, and cGMP standards.

You will work with a team of experienced validation experts who ensure that our processes and equipment perform to meet the highest standards of product safety, quality, and regulatory compliance across existing products and new products that are being introduced to our site.

Responsibilities

Coordinate, implement, and participate in equipment, process, and software validation activities to maintain regulatory compliance.

Develop, execute, and maintain validation master plans, project schedules, protocols, reports, and investigations.

Review, approve, and manage quality documents, change control, exception events, and corrective actions.

Train team members, support continuous improvement, and ensure cGMP compliance across production areas.

Communicate validation activities to peers and management; elevate issues as needed.

Qualifications

Bachelor's degree in engineering or a scientific discipline required.

Minimum 3 years' validation / QA experience in medical device manufacturing (plastics, moulding, assembly).

Solid understanding of cGMP and regulatory requirements.

Strong communication, interpersonal, troubleshooting, and organisational skills.

Ability to work independently and as part of a team, prioritise tasks, and multitask effectively.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.

Equal Opportunity Employer / Veterans / Disabled.

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Seniority level

Entry level

Employment type

Full-time

Job function

Engineering and Information Technology

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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