CSV Validation Engineer — Pharma GMP Specialist

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Performance bonus

Share options

Pension scheme

Private medical insurance

Career development

Succession planning

Education allowance

Wellness activities

Job summary

Grifols is seeking an experienced CSV Validation Engineer to join our Validation team. You will serve as SME for Computer System Validation across major projects, validating software, equipment and cloud platforms to meet GMP and data integrity standards.

You will collaborate with Quality, Operations, IT and Maintenance, ensuring adherence to global validation standards and regulatory expectations while supporting audits and documentation efforts.

Qualifications

• Experience in CSV/CSA and quality within biopharma.
• Experience validating MES, EBR, LIMS, SaaS/cloud platforms.
• Knowledge of GxP, cGMP, FDA 21 CFR Part 11, EU Annex 1, ISPE GAMP5.
• Experience executing FAT, SAT, IQ, OQ, PQ, QRM, commissioning.
• Data integrity assessments and ALCOA principles.
• Strong technical documentation skills.
• Audits during FDA/HPRA and internal audits.
• Cross-functional collaboration across Quality, Operations, IT.

Responsibilities

• Write, review and execute Validation Protocols and Reports (Equipment, software/automation, and enterprise systems).
• Review change controls and assess impact on validated systems and validation requirements.
• Represent Validation at internal and external audits by regulatory agencies (HPRA, FDA).
• Generate and review CSV project docs (URs, protocols, reports) and SOPs.
• Support validation activities including hands-on execution (FAT, SAT, IQ, OQ, PQ, UAT).
• Maintain Site Validation Master Plan (VMP) and Project VMPs, define validation approach and requalification requirements.
• Complete risk assessments and closure of CAPAs.
• Develop solutions and lead qualification/validation efforts across departments.

Skills

CSV/CSA experience

GxP qualification

Data integrity

Documentation skills

Audits support

Cross-functional work

MES/EBR/LIMS validation

SaaS/cloud platforms

FAT/SAT/IQ/OQ/PQ

Regulatory compliance

Education

Science/Engineering degree

Tools

MES

EBR

LIMS

SCADA

BMS

PCS

DCS

Job description

Grifols is seeking an experienced CSV Validation Engineer to join our Validation team. You will serve as SME for Computer System Validation across major projects, validating software, equipment and cloud platforms to meet GMP and data integrity standards.

You will collaborate with Quality, Operations, IT and Maintenance, ensuring adherence to global validation standards and regulatory expectations while supporting audits and documentation efforts.