Overview
Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company that develops, produces and markets innovative medicines, solutions and services in more than 110 countries and regions. We are committed to equal employment opportunities that foster an inclusive environment.
The Cleaning Validation Engineer will represent the Validation team in leading validation projects and driving strategic initiatives. This role is responsible for planning and implementing Cleaning validation strategies for major capital projects and serving as the primary Validation representative in technical forums, including internal and external audits. Initial focus areas will include Equipment Qualification, Utilities, Process Validation, Aseptic Process Validation, and Cleaning Validation.
What You'\u2019ll Do
Write, review, and execute validation protocols and reports for Cleaning, Equipment, Steam Sterilisation, and Process Validation, ensuring compliance with global and site-specific quality and validation standards.
Review change controls, assess the impact on validated systems, and define appropriate validation requirements.
Represent the Validation function during internal and external regulatory inspections, including inspections by HPRA and FDA.
Prepare and review project documentation, including User Requirement Specifications (URS), validation protocols, final reports, and Standard Operating Procedures (SOPs).
Support validation activities through documentation review and hands-on execution to ensure equipment cleaning and processes meet current GMP requirements and industry standards.
Maintain the Site Validation Master Plan (VMP) and associated project-level VMPs, defining validation strategies, requalification requirements, study scope, and frequency.
Execute and coordinate re-validation activities as required.
Complete risk assessments, manage deviations, and ensure timely closure of CAPAs.
Independently resolve complex technical challenges, demonstrating strong problem-solving skills and the ability to adapt to changing priorities.
Collaborate cross-functionally with Operations, Quality, Engineering, and Maintenance to lead qualification and validation activities supporting site projects.
Review and analyse validation data to ensure scientific robustness, regulatory compliance, and data integrity.
Perform additional validation-related duties as assigned by the Manager or Director.
Act as an authorised signatory for validation documentation, with delegated authority from the Validation Manager, where appropriately qualified.
What You'\u2019ll Bring
A degree in Science, Engineering, or a related discipline, or a minimum of 5 years’ experience in a Validation role within the pharmaceutical or regulated manufacturing sector.
Proven project management experience, with the ability to plan, coordinate, and execute validation activities across multiple workstreams.
Hands-on experience executing Cleaning, Process, Aseptic Process, and Software Validation within a GMP manufacturing environment.
Demonstrated experience working in a Quality or Validation function within the pharmaceutical industry.
Strong technical writing and analytical skills, with experience authoring and reviewing validation documentation and reports.
Solid knowledge of current Good Manufacturing Practices (cGMPs) and relevant industry, regulatory, and federal guidelines.
Experience representing organisations during internal (corporate) audits and external regulatory inspections, including FDA and HPRA.
Working knowledge of HTM 01 (Part C – Steam Sterilisation), including autoclave systems.
Familiarity with ISO 14644 (Cleanrooms and Associated Environments).
Strong understanding of EU GMP Annex 1 (Manufacture of Sterile Medicinal Products).
Experience working within an aseptic manufacturing environment.
Proficiency with Microsoft Word, Excel, and Access.
Strong interpersonal and communication skills, enabling effective collaboration with Operations, Quality, Engineering, and Maintenance teams.
Our Benefits Include
A highly competitive salary
Group pension scheme with contribution options of 1.5%, 3%, 5% or 7%, with company matching
Private medical insurance for the employee
Ongoing opportunities for career development within a rapidly expanding organization
Strong focus on succession planning and internal promotion
Education and professional development allowance
Wellness and social initiatives, including activities such as padel and summer events
Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3
Learn more about Grifols
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