Job Summary
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* This role is focused on ensuring the effectiveness and efficiency of our validation processes,
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* Coordinating with cross-functional teams to plan and execute validation activities,
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* Developing and implementing global validation standards and procedures,
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* Ensuring compliance with regulatory requirements and industry best practices.
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About the Role
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The Validation Engineer will play a key part in ensuring that our manufacturing processes meet the highest standards of quality and safety. This involves preparing and executing validation activities, monitoring project status, and ensuring timely updates.
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Key Responsibilities:
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* Validation Scheduling: Assess validation requirements, monitor project status, and ensure timely updates.
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* Status Reports & Support: Maintain validation status through monthly reports and meetings, collaborating with project managers to adhere to schedules.
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* Validation Standards: Ensure cGMP compliance, stay updated on validation innovations, and implement global and AICL, CSV documentation and procedures.
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* Validation Execution & Approvals: Execute and approve validation protocols, review project change controls, and prepare necessary documentation and reports.
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Requirements
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To be successful in this role, you will need:
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* Clear Communication & Justification: Effectively communicate and justify validation positions in SDLC discussions, applying relevant regulatory and industry knowledge.
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* Global Collaboration & Project Management: Work with global stakeholders, manage local validation projects, and contribute to larger cross-functional projects as a representative of the Validation team.
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* Education: Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.
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Benefits
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This is a permanent full-time position based in Tralee, Ireland. The successful candidate will be 100% onsite / in the office.
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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.