Cleaning Validation Engineer Lead
Dublin, IE
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
POSITION SUMMARY:
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.
What you'll do
- 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.
What you'll 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.
- Demonstrated project management experience with the ability to plan, coordinate, and deliver complex validation activities.Hands‑on experience executing Cleaning Validation, Process Validation, Aseptic Process Validation, and Software Validation for manufacturing systems.
- Proven experience working within a Quality or Validation function in a GMP pharmaceutical environment.Excellent technical writing and analytical skills, with experience authoring and reviewing validation documentation.Strong working knowledge of cGMPs, regulatory expectations, and industry/federal guidelines.
- Experience representing organizations during corporate audits and regulatory inspections, including FDA and HPRA.Working knowledge of HTM 01 (Part C – Steam Sterilisation) and autoclave systems.Familiarity with ISO 14644 (Cleanrooms and Associated Environments).
- Strong understanding of EU GMP Annex 1 – Manufacture of Sterile Medicinal Products.Experience working in an aseptic manufacturing environment.Proficiency in Microsoft Word, Excel, and Access.
- Strong interpersonal and communication skills, enabling effective collaboration across multiple departments.
Our Benefits Include:
- 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
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you#LI-FD1
Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3