OverviewWe are looking for an experienced QA Validation Engineer to play a key role in the development and upkeep of the site validation programme, ensuring all regulatory, quality, and compliance requirements are met.ResponsibilitiesCoordinate, oversee, and participate in the validation and QA of site equipment, utilities, processes, and software in compliance with FDA, European cGMP, and GAMP standards.Develop, maintain, and execute the Site Validation Master Plan.Develop, maintain, and execute project validation plans and schedules.Prepare validation protocols and final reports to cGMP standards.Conduct validation investigations and implement corrective actions.Create, review, and approve quality documents and test data.Manage validation, exception event, and change control processes.Maintain and track validation equipment, where applicable.Complete all required training before performing any task.Document all activities in line with cGMP requirements.Update validation procedures, work instructions, and batch documentation to reflect best practices.Provide cross-training within the team and support the training of new members.Participate in continuous improvement initiatives for manufacturing, quality, safety, and training systems.Coordinate activities to maximise team effectiveness.Ensure overall cGMP compliance within production areas.Communicate with peers and management, escalating events or concerns where necessary.RequirementsQualification and/or degree in an engineering or scientific discipline.3+ years’ validation or quality experience in medical device plastics processing, moulding, or assembly operations.3+ years’ knowledge of cGMP and regulatory requirements relating to the medical device industry.Strong written and verbal communication, presentation, and troubleshooting skills.Effective interpersonal and organisational abilities.Able to work both independently and as part of a team.Capable of prioritising tasks and managing multiple responsibilities simultaneously.Strong communication and motivational skills to identify, document, action, and resolve validation or QA needs promptly.High level of autonomy, initiative, and commitment to ‘Right First Time’ principles.Adheres to all procedures, policies, and guidelines ensuring compliance with cGMP, ISO/FDA regulations, and company standards.Persistence and determination to ensure timely closure of issues.To discuss this role in more detail, contact Corné at 0949316002 or corne@dillones.ie for a confidential discussion.
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