CSV Validation Engineer – Grifols
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CSV Validation Engineer
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Position Summary
The
CSV Validation Engineer
serves as the subject matter expert (SME) within the Validation team, leading validation strategies for major capital projects.
The 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, 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.
What You'll Do
Write, review and execute Validation Protocols and Reports (for equipment, software/automation, and enterprise software systems) ensuring compliance with 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 internal and external audits by regulatory agencies, including HPRA and FDA.
Generate and review CSV project documentation (User Requirement Specifications, validation protocols, reports, etc.) and Standard Operating Procedures.
Support validation activities including review of documentation and 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 VMPs, defining the validation approach for each piece of equipment, system, process, and the requalification requirements including study requirements and frequency.
Execute/co-coordinate re-validation activities as required.
Complete risk assessments and close corrective and preventive actions.
Develop alternative solutions to problems, handle highly complex problems independently, and collaborate with Operations, Quality, IT and Maintenance to lead qualification and validation efforts in support of site projects.
What You'll Bring
Project Management Experience.
Hands-on knowledge of validation execution.
Experience validating MES/EBR/LIMS and other enterprise systems (SaaS/cloud-based).
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 the pharma sector.
At least 2 years of equipment qualification experience (GAMP, equipment life-cycle FAT, SAT, DQ, QRM, IQ, OQ, PQ) and experience performing data integrity assessments and data mapping.
Excellent technical writing and analytical skills.
Familiarity with cGMPs and federal guidelines.
Experience with Word, Excel and Access.
Strong interpersonal skills for interactions with other departments.
Degree in Science/Engineering and/or = 4 years CSV/CSA validation experience.
Experience representing client companies during internal (corporate) and external (FDA, HPRA) audits.
Experience within aseptic manufacturing environment.
PCS/DCS and automation experience.
Key Competencies
Project Management skills.
Computer System Validation and CSA knowledge.
Commissioning and Qualification.
Documentation (SOPs, protocols, reports).
Data Integrity, data mapping and governance (ALCOA principles).
Auditing.
Strong communication/presentation skills during audits.
Familiarity with IT infrastructure and applications in pharmaceutical/biopharmaceutical environments.
Problem-solving and organisational skills.
Our Benefits Include
Highly competitive salary.
Group pension scheme with company matching.
Private medical insurance.
Ongoing career development opportunities.
Succession planning and internal promotions.
Education allowance.
Wellness activities (social events, Padel, summer events).
Location: Grange Castle International Business Park, Grange, Co.
Dublin, D22 K2R3.
Be part of a global company that has been improving healthcare since ****.
We encourage everyone who meets the qualifications to apply.
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