CSV Validation Engineer – GMP, GxP & Cloud Systems

Grifols Shared Services North America, Inc; Ireland; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Highly competitive salary

Annual performance-based bonus

Shares options scheme

Group pension scheme

Private Medical Insurance

Education allowance

Wellness activities

Job summary

Grifols Shared Services North America, Inc. seeks an experienced CSV Validation Engineer to join our Validation team.

You will be a subject matter expert for CSV and validation activities across major capital projects, validating software, equipment, manufacturing systems, and cloud platforms to ensure GMP compliance and data integrity. This role collaborates with Quality, Operations, IT, Engineering and Maintenance in a highly regulated pharmaceutical environment, driving risk assessments,

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.
• Hands-on experience validating MES, EBR, LIMS, and cloud-based platforms.
• Proven experience with full lifecycle activities: FAT, SAT, IQ, OQ, PQ, QRM.
• Knowledge of FDA 21 CFR Part 11, EU Annex 1, data integrity concepts.
• Strong documentation skills including SOPs, validation plans, protocols, and reports.
• Experience supporting audits by FDA, HPRA, and internal teams.

Responsibilities

• Write, review and execute validation protocols and reports for equipment, software, and enterprise systems.
• Review change controls and define validation requirements.
• Represent Validation at audits by regulatory agencies (FDA, HPRA).
• Generate and review CSV documentation and SOPs.
• Support validation activities including FAT, SAT, IQ, OQ, PQ, UAT.
• Maintain Site Validation Master Plan and project VMPs.
• Coordinate re-validation activities and risk assessments.
• Lead qualification efforts across cross-functional teams.

Skills

CSV/CSA

GxP & cGMP

Documentation

Audit readiness

Project management

Cross-functional collaboration

Software validation

Data integrity

Education

Degree in Science/Engineering

Tools

MES

LIMS

SaaS/Cloud platforms

SCADA

Job description

Grifols Shared Services North America, Inc. seeks an experienced CSV Validation Engineer to join our Validation team.

You will be a subject matter expert for CSV and validation activities across major capital projects, validating software, equipment, manufacturing systems, and cloud platforms to ensure GMP compliance and data integrity. This role collaborates with Quality, Operations, IT, Engineering and Maintenance in a highly regulated pharmaceutical environment, driving risk assessments,