Validation Engineer

This global healthcare company is committed to improving the health and well-being of people all over the world by developing, producing, and providing innovative healthcare services and solutions in more than 110 countries globally. With more than 30,000 employees in 30 countries around the world, this biopharmaceutical leader improves the lives of patients who suffer from many chronic, rare, prevalent, and sometimes life‑treathing diseases. With a significant R&D pipeline and a diverse commercialised product portfolio in therapy areas such as immunology, hepatology, and intensive care to name but a few, this organisations has increased year on year its investment in Ireland, in addition to the widened scope of roles positioned at its operation in Dublin, which is a state of the art biologics manufacturing plant and one of the premier sites in Dublin. With its continued expansion in Ireland and internationally, a need has arisen in the organisation for a Validation Engineer to represent the validation team as Technical Lead CSV SME for validation projects at this growing site, at an opportune time to join the business.

This role will be responsible for planning and implementing validation strategies for major capital projects.

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• Represent Validation at technical forums including external and internal audits.
  
• Write, review and execute Validation Plans, Protocols and Reports for the new software and automated equipment and enterprise and SAAS / cloud-based systems.
  
• Be a data integrity SME and champion for the site, ensuring compliance to all relevant global and local quality and validation procedures /standard. Initial requirements to focus on the areas of automation and CSV.
  
• Supporting validation activities including review of documentation hands‑on execution of validation activities (FAT, SAT, IQ, OQ, PQ, UAT, etc) to ensure equipment /software meets current GMP requirements and industry standards.
  
• Maintain the Site Validation Master Plan (VMP) and associated Project VMP's, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Co‑ordinate Re‑Validation activities as required.
  
• Completion of risk assessments, closure of corrective and preventive actions.
  
• Develops alternative solutions to problems, handles Highly complexity problems independently. Demonstrates technical knowledge and ability to adapt to changing circumstances. Works with other departments Operations, Quality, IT and Maintenance) to lead qualification and validation efforts in support of site projects.
  
• Performs other validation associated activities as defined by Manager or Director.
  

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• Degree in Science/Engineering or related discipline.
  
• Minimum of 3 years' validation experience in pharma, biotech, medical devices or diagnostics.
  
• Hands‑on knowledge and execution of Validation.
  
• Experience in validation of MES /EBR/LIMS and other enterprise systems (SAAS /cloud-based systems).
  
• Experience with automated equipment (SCADA/BMS / DCS).
  
• Experience with performing data integrity assessments and data mapping.
  
• At least 2 years of Equipment qualification experience (GAMP, Equipment life cycle FAT, SAT, DQ, QRM, IQ, OQ, PQ).
  
• Familiarity with cGMPs and industry and federal guidelines required.
  
• Experience with internal (corporate) audits and external (HPRA and FDA) audits. xcfaprz
  
• Experience within aseptic manufacturing environment
  
• PCS /DCS and automation experience
  

To learn more about this role, apply now or contact Anita Osibuamhe at or for a confidential chat.