CSV Validation Engineer – GMP & Cloud Systems

Grifols, S.A; Leinster; On-site; EUR 75,000 - 110,000; Full time

Benefits offered by this job

Salary that reflects experience

Annual performance bonus

Shares options scheme

Private Medical Insurance

Job summary

Grifols, S.A seeks an experienced CSV Validation Engineer to join the Validation team in Ireland. You will act as SME for Computer System Validation across major capital projects, validating software, equipment, and cloud platforms to ensure GMP compliance and data integrity.

You will work with Quality, Operations, IT and Maintenance to lead validation activities, maintain the VMP, and support audits by HPRA and FDA. Strong CSV/CSA expertise is essential.

Qualifications

• Degree in Science/Engineering or related discipline.
• 3+ years' experience in CSV/CSA, Validation, or Quality in biopharma.
• Strong experience in CSV/CSA and qualification of GxP systems and equipment.
• Hands-on validation of MES, EBR, LIMS, and cloud-based platforms.
• Experience with FAT, SAT, IQ, OQ, PQ, and commissioning activities.
• Knowledge of GxP, cGMP, FDA 21 CFR Part 11, EU Annex 1, data integrity and ISPE GAMP 5.
• Data integrity assessments, data mapping and governance per ALCOA.
• Strong project management, analytical, problem-solving and stakeholder skills.

Responsibilities

• Write, review and execute validation protocols and reports for equipment, software and enterprise systems.
• Review changes and assess impact on validated systems and define validation requirements.
• Represent Validation at internal and external audits (HPRA, FDA).
• Create and review validation docs like URS, protocols, reports and SOPs.
• Support validation activities including FAT/SAT/IQ/OQ/PQ/UAT.
• Maintain Site Validation Master Plan and project VMPs; coordinate re-validations as needed.
• Perform risk assessments and close corrective and preventive actions.
• Collaborate across Quality, Operations, IT and Maintenance to lead qualification efforts.

Skills

CSV

CSA

GxP

Data integrity

ALCOA

IQ/OQ/PQ

Project management

Stakeholder management

Cross-functional collaboration

Education

Degree in Science or Engineering

Tools

MES

LIMS

SCADA

SaaS/Cloud platforms

MES/EBR

Job description

Grifols, S.A seeks an experienced CSV Validation Engineer to join the Validation team in Ireland. You will act as SME for Computer System Validation across major capital projects, validating software, equipment, and cloud platforms to ensure GMP compliance and data integrity.

You will work with Quality, Operations, IT and Maintenance to lead validation activities, maintain the VMP, and support audits by HPRA and FDA. Strong CSV/CSA expertise is essential.