Validation Engineer

2 weeks ago

Sligo, Ireland Sterling Engineering Ltd - Ireland & Europe Full time

QA Validation Engineer
We are seeking a driven 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.
For a confidential conversation about the role contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.
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