CSV Engineer | GxP Validation Specialist

EFOR; Limerick; On-site; EUR 60,000 - 90,000; Full time

Job summary

Efor Group is seeking an experienced CSV Engineer in Limerick to deliver compliant validation for pharmaceutical projects. You will plan, execute, and oversee IQ/OQ/PQ protocols for GxP systems and lead CSV activities across automation, equipment, and processes.

The role requires a strong knowledge of FDA/EMA/ICH guidelines, excellent documentation, and the ability to collaborate with QA, IT, Engineering, and Manufacturing teams to meet project milestones and support regulatory inspections.

Qualifications

• Bachelor’s degree in engineering, CS, life sciences or related field.
• 3+ years in Computer System Validation in pharma/biotech/medical devices.
• Strong knowledge of GxP regulations and validation guidelines.
• Experience with automation/IT systems (PLC, SCADA, MES, LIMS, DCS) is a plus.

Responsibilities

• Plan, write, review, and execute validation protocols for GxP systems.
• Lead CSV activities for new and existing automated systems.
• Develop and review URS, DQ, and Traceability Matrices.
• Ensure compliance with FDA, EU regulations and standards.
• Manage deviations, changes, and CAPA investigations.
• Collaborate with QA, IT, Engineering, Manufacturing, and PM teams.
• Support audits and inspections as CSV SME.
• Maintain validation schedules and complete documentation.

Skills

GxP knowledge

Validation expertise

Communication skills

Documentation

Education

Bachelor’s Degree in Engineering, Computer Science, Life Sciences

Tools

PLC

SCADA

MES

LIMS

DCS

Job description

Efor Group is seeking an experienced CSV Engineer in Limerick to deliver compliant validation for pharmaceutical projects. You will plan, execute, and oversee IQ/OQ/PQ protocols for GxP systems and lead CSV activities across automation, equipment, and processes.

The role requires a strong knowledge of FDA/EMA/ICH guidelines, excellent documentation, and the ability to collaborate with QA, IT, Engineering, and Manufacturing teams to meet project milestones and support regulatory inspections.