QA Validation Engineer
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Job Location:
Monthly Salary:
Posted on:
07-11-2025
Vacancies:
1 Vacancy
Job Summary
We are now hiring a QA Validation Engineer on our Ballytivnan Medical Device site in Sligo. In this role you will join AbbVies 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 :
- Bachelors 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
