QA Validation Engineer
AbbVie
QA Validation Engineer
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.
Locations
- Sligo, ie
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
60,000 - 90,000 USD / yearly
Source: AI estimated from job description
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Validation planning and executionintermediate
- Regulatory compliance (FDA, cGMP)intermediate
- Quality document management and change controlintermediate
- Team training and continuous improvementintermediate
- Effective communication and issue escalationintermediate
Required Qualifications
- Experience in validation engineering within the medical device or pharmaceutical industry (experience)
- Knowledge of FDA regulations, cGMP standards, and AbbVie quality requirements (experience)
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
Benefits
- general: Join a team of experienced validation experts
- general: Support development and maintenance of site validation program
- general: Work on existing and new products ensuring highest standards of safety and quality
Tags & Categories
QA Validation Engineer
AbbVie
QA Validation Engineer
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.
Locations
- Sligo, ie
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
60,000 - 90,000 USD / yearly
Source: AI estimated from job description
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Validation planning and executionintermediate
- Regulatory compliance (FDA, cGMP)intermediate
- Quality document management and change controlintermediate
- Team training and continuous improvementintermediate
- Effective communication and issue escalationintermediate
Required Qualifications
- Experience in validation engineering within the medical device or pharmaceutical industry (experience)
- Knowledge of FDA regulations, cGMP standards, and AbbVie quality requirements (experience)
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
Benefits
- general: Join a team of experienced validation experts
- general: Support development and maintenance of site validation program
- general: Work on existing and new products ensuring highest standards of safety and quality
Tags & Categories