Cleaning Validation Engineer Lead

The Cleaning Validation Engineer Lead is a senior member of the Validation function, responsible for leading validation activities and driving strategic initiatives for major capital projects at the new GWWO facility. This role serves as the primary Validation representative in technical forums, including internal governance meetings and external regulatory inspections.

The position has accountability for planning, authoring, reviewing, and executing validation strategies and documentation in compliance with global and local quality standards. Primary focus areas include Cleaning Validation, Equipment Qualification, Utilities, Process Validation, and Aseptic Process Validation, with a strong emphasis on GMP compliance and inspection readiness.

• Lead the preparation, review, and execution of Validation Plans, Protocols, and Reports for Cleaning, Equipment, Steam Sterilisation, and Process Validation in accordance with cGMP and regulatory requirements.


• Review and assess change controls, evaluate impact to validated systems, and define appropriate validation and re‑qualification requirements.


• Represent the Validation function during internal and external regulatory inspections, including those conducted by HPRA and FDA.


• Generate, review, and approve validation documentation including User Requirement Specifications (URS), protocols, reports, and SOPs.


• Provide hands‑on execution and oversight of validation activities to ensure equipment cleaning and processes meet current GMP and industry standards.


• Maintain the Site Validation Master Plan (VMP) and associated Project VMPs, defining validation approaches, study requirements, requalification strategies, and frequencies.


• Execute and coordinate revalidation activities in line with change management and lifecycle requirements.


• Perform risk assessments, manage deviations, and ensure timely closure of CAPAs.


• Independently resolve complex technical challenges, applying sound scientific judgment and adaptability in a dynamic manufacturing environment.


• Collaborate cross‑functionally with Operations, Quality, Engineering, and Maintenance to lead qualification and validation efforts supporting site projects.


• Review and analyse validation data to verify adequacy, data integrity, and regulatory compliance.


• Perform additional validation‑related activities as assigned by the Manager or Director.


• Act as a delegated signatory for validation documentation, with appropriate qualification and authorization from the Validation Manager.

• Highly competitive salary package


• Group pension scheme with contribution options of 1.5%, 3%, 5%, or 7%, with company matching


• Private medical insurance for the employee


• Ongoing career development opportunities within a rapidly expanding organization


• Strong commitment to succession planning and internal promotion


• Education and professional development allowance


• Wellness and social initiatives, including activities such as padel and summer events