Summary: A CQV Engineer is required to join the Solution Preparation area at our client site in East Cork, a leading pharmaceutical facility. The successful candidate will lead and coordinate CQV activities in alignment with the sites project strategy. This role involves close collaboration with a range of functions, including Process Engineering, Operations, Engineering, Quality, EHS, Logistics, and Lean & Digital, to understand requirements and develop and execute an effective, compliant validation strategy. Responsibilities: Guide CQV activities for solution prep, ensuring timely execution and compliance with industry regulations. Develop, review, approve and execute the commissioning, installation and qualification protocols, ensuring all issues identified during execution are managed correctly, efficiently and in accordance to site/project procedures. Generate, review and approve Validation Plan, SRA, DQ, and URS. Manage and coordinate Solution Prep equipment commissioning and qualification activities. Review and approve vendor/ field turnover packs for all equipment associated to the Solution Prep area. Act as the CQV point of contact between clients, internal teams, and external vendors to drive project success. Provide technical oversight and guidance to resolve issues as they arise in a collaborative manner. Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards. Qualifications & Experience: Relevant qualification (degree) and/or a minimum of 10 years experience in the biotech or pharmaceutical industry, with a strong background in qualifying GxP systems. Prior experience operating as a senior CQV Engineer with a solid technical background. Previous experience collaborating with vendors such as BCD, Hetch, Rockwell, and/or exposure to solution preparation or formulation processes. Strong understanding of Risk-Based Validation (RBV) principles and hands-on experience deploying and executing RBV in line with ISPE guidelines within a large capital project environment. Experience working with digital C&Q platforms such as Kneat Solutions. Clear knowledge of EU and other global regulatory requirements, ensuring CQV activities are delivered in full compliance with all applicable regulations and guidelines.