Validation Engineer

at  Merck Group

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Reporting to the Senior Validation Engineer – Filtration Site 2 (FS2), the Validation Engineer is responsible for the design and execution of F2.0 validation project and strategies to support the implementation of Validation Master Plans and Qualification programmes.
The Validation Engineer works as part of a cross-functional team to deliver continuous improvements and exceed customers’ expectations, leading and supporting validation activities to ensure delivery of effective and well-documented qualification programmes.
The Validation Engineer will perform all activities in an efficient and competent manner with due regard to safety and quality, while ensuring a positive team environment and a focus on continuous improvement.

Duties

• Responsibility for the validation of manufacturing and all associated processes for the new manufacturing facility located in Blarney.
• Execute and complete process, systems and equipment validations in accordance with Validation Master Plans, company policies and project schedules.
• Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality standards and Regulatory requirements.
• Participate in cross-functional teams to establish validation strategies and objectives to support process and equipment changes.
• Ensure all departments understand and comply with requirements defined in validation programmes, provide training as necessary.
• Maintain ongoing understanding and knowledge of requirements for validation in compliance with applicable regulations and guidance documents, provide updates to department management and cross-functional teams.
• Participate in the review of validation practices and trends, identify opportunities for continuous improvement and complete improvement projects.
• Monitor the progress of validation projects to ensure adherence to schedule and provide regular stakeholder updates.