Job Location: Tipperary

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 Lead the Equipment Qualification aspects of Projects on site. Perform root cause analysis of Project issues when required. Effectively communicate and discuss related day to day activity and concerns within the team for efficiency and performance improvement Coordinate with design consultants as required and respective user departments for the design/manufacturing of equipment Review and approval on detailed designs as submitted by vendors Ensure project execution work and follow ups with different depts (QA, QM, Operations) to meet project completion within stipulated time frame Minimum Qualifications and Experience: Level 7 /8 degree in Engineering, Science, or a related technical field. 5+ years of experience in validation, engineering, or quality roles within pharmaceutical, biotech, medical device, or similar regulated industries. Strong knowledge of validation principles, GxP requirements, and risk‑based approaches. Experience with equipment qualification, process validation, and/or computer system validation is an advantage. Excellent project management, documentation, and communication skills. Ability to work independently and collaboratively in a fast‑paced environment. Experience with automation systems, data integrity principles, or digital validation tools Please note, we do not require agency assistance with this role.

Role Summary: The Project Engineer will support the delivery of capital and process improvement projects within a regulated pharmaceutical manufacturing environment. The role involves managing projects from concept through to commissioning and handover, ensuring they are completed safely, on time, and within budget. Core Duties and Responsibilities: Manage end-to-end equipment projects Develop and execute project […]