Validation Engineer

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 [email protected] By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.