CSV Validation Engineer

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. 

Posiition Summary

The CSV Validation Engineer serves as the subject matter expert (SME) within the Validation team, leading validation strategies for major capital projects. This role involves planning and executing validation activities for new software, automated equipment, and enterprise or cloud-based systems (SaaS). The engineer will represent Validation in technical forums, including internal and external audits, and act as a site champion for data integrity. Responsibilities include authoring and reviewing validation plans, protocols, and reports while ensuring compliance with global and local quality standards. Initial focus areas will include automation and CSV, supporting GxP compliance and operational excellence. 

KEY RESPONSIBILITIES

• Write, review and execute Validation Protocols and Reports (for Equipment, software /automation, and enterprise software systems) 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 CSV project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
• Supporting validation activities including review of documentation hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ, UAT, etc) to ensure equipment /software 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.
• Develops 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, IT and Maintenance) to lead qualification and validation efforts in support of site projects.
   

KEY COMPETENCIES

• Project Management skills
• Computer System Validation and knowledge of CSA
• Commissioning and Qualification
• Documentation (Writing SOPs, Protocols, Reports)
• Data Integrity, data mapping and data governance (ALOCA principles)
• Auditing
• Strong communication /presentation skills during internal/external audits.
• Familiarity with IT infrastructure and applications in a pharmaceutical/biopharmaceutical environment.
• Ability to collaborate in cross-functional teams. Problem-solving and organisation skills.
   

PERSON SPECIFICATION 

• Project Management Experience
• Hands-on knowledge of execution of Validation
• Experience in validation of MES /EBR/LIMS and other enterprise systems (SAAS /cloud-based systems)
• Experience with automated equipment (SCADA/BMS / DCS)
• Solid knowledge of GxP, FDA 21 CFR Part 11, EU Annex 1 and ISPE GAMP 5 guidelines.
• Experience in a Quality or Validation Role within Pharma sector
• At least 2 years of Equipment qualification experience (GAMP, Equipment life cycle FAT, SAT, DQ, QRM, IQ, OQ, PQ)
  Experience with performing data integrity assessments and data mapping
• Excellent Technical Writing and analytical skills.
• Familiarity with cGMPs and industry and federal guidelines required.
• Experience with Word, Excel and Access computer applications.
• Strong interpersonal skills for interactions with other departments.
• Degree in Science/Engineering and/or Min 4 years CSV /CSA Validation experience
• Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits
• Experience within aseptic manufacturing environment
• PCS /DCS and automation experience

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Padel, 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

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Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3      

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