Overview
We 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.
Responsibilities
* Coordinate, 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.
Requirements
* Qualification 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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