Role Summary: Our client, a pharmaceutical company in Tipperary is looking to hire a Validation Project Engineer The Validation Project Engineer is responsible for planning, executing, and managing validation activities to ensure equipment, systems, and processes meet regulatory, quality, and operational requirements. This role supports cross‑functional teams, leads validation projects from concept through completion, and ensures compliance with industry standards and internal procedures. Core Duties and Responsibilities: Lead validation projects across equipment, utilities, facilities, and manufacturing processes, ensuring timely and compliant execution. Develop and execute validation documentation, including URS, DQ, IQ, OQ, PQ, risk assessments, and validation reports. Manage project timelines, resources, and deliverables while coordinating with the wider engineering team quality, operations, and external vendors. Ensure compliance with regulatory guidelines (e.g. FDA, GAMP 5) and internal quality systems. Support equipment commissioning, FAT/SAT activities, and process qualification efforts. Analyze validation data, identify trends or issue, and recommend corrective or preventive actions. Contribute to continuous improvement initiatives, including process optimization and standardization of validation practices. Ensure that engineering, qualification and validation records are developed and maintained as per cGMP and GDP requirements Develop lifecycle activities including device innovation, concept generation, design reviews, specification development, device industrialization, manufacturing process development, validation and design verification…
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