Cleaning Validation Engineer (12 month)
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Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
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. |
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 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 responsibilities include authoring reviewing and executing Validation Plans Protocols and Reports for the new GWWO facility ensuring full compliance with global and local quality standards and validation procedures. Initial focus areas will include Equipment Qualification Utilities Process Validation Aseptic Process Validation and Cleaning Validation.
What youll do
- Write review and execute validation protocols and reports for Cleaning Equipment Steam Sterilisation and Process Validation ensuring compliance with global and sitespecific 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 handson execution to ensure equipment cleaning and processes meet current GMP requirements and industry standards.
- Maintain the Site Validation Master Plan (VMP) and associated projectlevel VMPs defining validation strategies requalification requirements study scope and frequency.
- Execute and coordinate revalidation activities as required.
- Complete risk assessments manage deviations and ensure timely closure of CAPAs.
- Independently resolve complex technical challenges demonstrating strong problemsolving skills and the ability to adapt to changing priorities.
- Collaborate crossfunctionally 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 validationrelated 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 youll 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.
- Handson 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
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply were excited to hear from you#LI-FD1
Location: Grange Castle International Business Park Grange Co. Dublin D22 K2R3
Required Experience:
IC
About Company
Explore Grifols' comprehensive, innovative and patient-centric biopharma and healthcare solutions.
