Pharma CSV Engineer - GMP Validation & Data Integrity

Y-Axis; Dublin; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Y-Axis in Ireland is seeking a seasoned CSV specialist to lead Computer System Validation activities in a pharmaceutical manufacturing environment. You will develop and execute key validation and quality documentation (URS/FRS, RTMs, validation protocols, VSRs) ensuring GMP, GAMP5 and 21 CFR Part 11 alignment, and collaborate with Automation, IT, QA and vendors.

You will oversee FAT/SAT, maintain SDLC templates, and ensure data integrity across MES, EBR and recipe management systems.

Qualifications

• 5+ years’ experience in Computer System Validation within pharmaceutical or life sciences manufacturing environments
• Expert knowledge of GAMP5 methodology
• GMP & Regulatory Compliance
• SDLC Documentation & Validation Lifecycle

Responsibilities

• Lead CSV activities across the validation lifecycle for manufacturing systems
• Develop and execute Qualification Plans, Test Plans, URS/FRS, RTMs and Validation Summary Reports
• Coordinate FAT/SAT and system acceptance testing with vendors and site teams
• Ensure data integrity and regulatory compliance across MES, EBR, and automation interfaces
• Maintain and improve validation templates and SDLC documentation

Skills

CSV Validation

GAMP5

Regulatory Compliance

SDLC Documentation

FAT/SAT Oversight

Data Integrity

Job description

Y-Axis in Ireland is seeking a seasoned CSV specialist to lead Computer System Validation activities in a pharmaceutical manufacturing environment. You will develop and execute key validation and quality documentation (URS/FRS, RTMs, validation protocols, VSRs) ensuring GMP, GAMP5 and 21 CFR Part 11 alignment, and collaborate with Automation, IT, QA and vendors.

You will oversee FAT/SAT, maintain SDLC templates, and ensure data integrity across MES, EBR and recipe management systems.