Senior Validation Engineer (Technical Lead)

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‑threatening 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 Senior Validation Engineer/Technical Lead to represent the validation team as Technical Lead for validation projects at this growing site, at an opportune time to join the business.

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• This role is responsible for the planning and implementation of validation strategies for major capital projects.
  
• Represent Validation at technical forum include external and internal audits. Initial requirements to focus on the areas of Equipment, Utilities, Process Validation, Aseptic Process Validation and Cleaning Validation.
  
• Write, review and execute Validation Protocols and Reports (for Equipment, Steam sterilisation, Utilities, Processes, Cleaning, and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards.
  
• Review change controls and assess impact of changes that affect validated systems and define validation requirements.
  
• Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
  
• Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
  
• Supporting validation activities including review of documentation and hands‑on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment 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 and deviations.
  
• Develop 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, and Maintenance) to lead qualification and validation efforts in support of site projects.
  
• Performs other validation associated activities as defined by Manager or Director.
  
• Evaluate and analyse validation data collected during projects, verify adequacy of the information and compliance with regulations. Performs reviewed activities in protocols. May have signature authority for Validation Manager with appropriate qualification.
  

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• Degree in Science/Engineering or related discipline.
  
• Minimum of 5 years' validation experience in pharma or biotech.
  
• Hands‑on execution of validation (cleaning, process, CSV, and aseptic process validation).
  
• Familiarity with cGMPs and industry and federal guidelines required.
  
• Strong interpersonal skills and ability to communicate effectively cross functionally.
  
• Experience with internal (corporate) audits and external (HPRA and FDA) audits.
  
• Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves.
  
• Familiarity with ISO‑14644 (Cleanrooms and Associated Environments.
  
• Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products). xcfaprz
  
• Experience within aseptic manufacturing environment
  

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