CSV Validation Engineer — GMP/Regulatory Expert

Grifols, S.A

Dublin

Hybrid

EUR 70,000 - 95,000

Full time

2 days ago

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Benefits offered by this job

Highly competitive salary

Annual bonus%

Shares options scheme

Group pension scheme

Private Medical Insurance

Job summary

Grifols, S.A. is seeking an experienced CSV Validation Engineer to join our Validation team.

You will act as an SME for Computer System Validation and validation activities across major capital projects within a highly regulated pharmaceutical environment. This role involves validating software, automated equipment, manufacturing systems, and cloud-based platforms to ensure GMP compliance, data integrity, and regulatory standards.

Qualifications

Degree in Science, Engineering, or related discipline, with 3+ years' experience in CSV/CSA, Validation, or Quality within biopharmaceuticals.
Strong experience in Computer System Validation (CSV), Computer Software Assurance (CSA), and qualification of GxP systems and equipment.
Hands-on experience validating MES, EBR, LIMS, SaaS/cloud-based platforms, and automated systems such as SCADA, BMS, PCS, and DCS.
Proven experience executing the full equipment and system lifecycle, including FAT, SAT, DQ, IQ, OQ, PQ, QRM, and commissioning/qualification activities.
Solid knowledge of GxP, cGMP, FDA 21 CFR Part 11, EU Annex 1, data integrity requirements, and ISPE GAMP 5 guidelines.

Responsibilities

Write, review and execute Validation Protocols and Reports for Equipment, software/automation, and enterprise software systems, ensuring compliance with global and local quality 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 Requirements Specifications, validation protocols, reports) and SOPs.
Support validation activities including hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ, UAT) to meet GMP requirements and industry standards.
Maintain the Site Validation Master Plan (VMP) and Project VMPs, defining validation approaches and requalification requirements, and coordinate Re-Validation as needed.
Complete risk assessments and close corrective and preventive actions.
Develop alternative solutions to problems and lead qualification/validation efforts across cross-functional teams.