QA Validation Engineer
AbbVie
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
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 join 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html