Validation Engineer
4 days ago
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 RoleAs 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.
- 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 oclancy@sterlingengineeringeu.com
By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Quality Assurance
- Industries: Pharmaceutical Manufacturing
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