CSV Validation Engineer: GMP & Data Integrity

Grifols, S.A

Dublin

On-site

EUR 70,000 - 100,000

Full time

2 days ago

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Benefits offered by this job

Salary growth

Annual bonus

Group pension

Private medical insurance

Career development

Job summary

Grifols in Ireland is seeking an experienced CSV Validation Engineer to join our Validation team. You will act as SME for Computer System Validation and validation activities across major capital projects, ensuring compliance with GMP, regulatory requirements and data integrity.

You will collaborate with Quality, Operations, IT and Engineering to validate software, automated equipment and cloud-based platforms, supporting audits by HPRA and FDA and contributing to site projects in a highly

Qualifications

Degree in Science, Engineering, or related discipline required.
3+ years' experience in CSV/CSA, Validation, or Quality in biopharma.
Strong experience with CSV/CSA, GxP systems, data integrity.

Responsibilities

Write/Review/Execute Validation Protocols and Reports for equipment and software.
Review change controls and define validation requirements.
Represent Validation at internal and external audits (HPRA, FDA).
Prepare/Review CSV documentation: URS, validation plans, protocols, reports, SOPs.
Support validation activities: FAT, SAT, IQ, OQ, PQ, UAT, etc.