Validation Engineer

1 week ago

Sligo, 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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