Our client is a global leader in their space, they offer a wide range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer for 95 years in the field of contrast media, this business team consists of over 2,600 people globally, continuously innovating with 10% of revenue dedicated to Research & Development across four centres around the world including a state-of-the-art manufacturing plant here in Ireland that is seeing consistent growth and investment.

They are currently searching for a Validation Lead to join the Quality Dept, for a permanent role at their Leinster site.

The Position

Key responsibilities would include:

• Responsible for leading the comprehensive validation support to all areas on site; Manufacturing and QC laboratory equipment, Automated Control Systems, Instrumentation, Facilities, Utilities, Manufacturing processes and Cleaning processes.
• Ensure that all systems conform to relevant regulatory requirements as well as company specifications and standards.
• Responsible for preparing, reviewing and approving Validation Documentation, such as URS, RTM, Risk Assessments, IQ, OP and PQ, ensuring highest EHS Standards are obtained.
• Responsible for field execution of Commissioning, Installation & Operational Qualifications (IQ/OQ).
• Responsible for the coordination of vendor packages to achieve streamlined Commissioning & Validation.
• Responsible for review of vendors as well as executing commissioning and validation documentation
• Responsible for initiation and completion of deviations/exceptions, CAPAs, and change controls for process systems including investigations relating to equipment performance.
• Provide technical leadership for all validation activities

The Person

• Level 8 Degree in Science, Engineering or related Technical-degree.
• 7-8 years of Pharmaceutical manufacturing experience.
• Experience in commissioning, qualification and validation activities in a GMP environment, including the generation of procedures, plans and policies.
• Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern Validation practices.

To discover more about this opportunity, apply now or contact Déanna Healy at HRM at +353 87 6369263 for a confidential discussion.