Overview
QA Validation Engineer to join Sligo base client on a contract basis to play a key role in ensuring site-wide validation and regulatory compliance.
About the Role
As a QA Validation Engineer, you will coordinate and maintain the site validation program, ensuring compliance with FDA, European cGMP, and GAMP standards. This is a hands-on role that involves planning and executing validation activities, managing quality processes, and driving continuous improvement initiatives across equipment, utilities, processes, and software systems.
Key Responsibilities
* Develop, execute, and maintain Validation Master Plans and Project Validation Plans.
* Prepare and execute validation protocols, reports, and investigations to cGMP standards.
* Lead validation and quality assurance for site equipment, processes, and software.
* Support regulatory compliance through robust documentation, audits, and process improvements.
* Manage change control, exception events, and corrective actions.
* Provide cross-training, mentorship, and support to team members.
* Actively contribute to continuous improvement in manufacturing, quality, and safety systems.
Requirements
* Degree in an engineering or scientific discipline.
* 3+ years’ experience in validation/quality within medical device plastics processing, molding, or assembly operations.
* Strong knowledge of cGMP and medical device regulatory requirements.
* Excellent communication, organizational, and troubleshooting skills.
* Ability to work independently and as part of a team, with strong prioritization and multitasking skills.
Contact
For a confidential conversation about the role contact Owen Clancy at oclancy@sterlingengineeringeu.com
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Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industries: Pharmaceutical Manufacturing
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