CSV Validation Engineer — GMP, MES & Cloud Platforms

Grifols

Dublin

On-site

EUR 70,000 - 100,000

Full time

3 days ago

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Benefits offered by this job

Competitive salary

Performance bonus

Share options

Group pension scheme

Private medical insurance

Education allowance

Wellness activities

Career development opportunities

Job summary

Grifols in Grange, Co. Dublin, is seeking an experienced CSV Validation Engineer to join the Validation team. The role focuses on computer system validation across major capital projects, ensuring GMP compliance, data integrity and regulatory readiness.

You will collaborate with Quality, Operations, IT and Engineering across site projects. The ideal candidate brings 3+ years in CSV/CSA within biopharma, hands-on experience with MES/LIMS, cloud platforms and strong audit exposure.

Qualifications

Degree in science or engineering with relevant CSV/CSA/Quality experience.
Strong knowledge of GxP, cGMP and data integrity concepts.
Experience validating MES, LIMS and cloud-based platforms.
Ability to lead validation activities with cross-functional teams.
Experience supporting audits by regulators (FDA/HPRA).

Responsibilities

Write, review and execute validation protocols and reports across equipment and software.
Assess change controls and define validation requirements for validated systems.
Represent Validation during internal and external audits.
Develop CSV project documents and SOPs with RFP and regulatory alignment.
Lead hands-on validation activities (FAT, SAT, IQ, OQ, PQ, UAT).
Maintain VMPs and coordinate re-validation activities as needed.
Perform risk assessments and drive corrective actions in QA/Operations.