CSV Engineer

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

Company Overview:

Efor Group is a leader in providing expert engineering solutions to major pharmaceutical and life sciences clients. We are expanding our team as part of an exciting new project in Limerick, and are seeking an experienced CSV Engineer to play a key role in delivering compliant, high-quality systems.

Key Responsibilities:

• Plan, write, review, and execute validation protocols (IQ/OQ/PQ) and associated reports for GxP-regulated systems.
• Lead Computer System Validation activities for new and existing automated systems, equipment, and processes.
• Develop and review risk assessments, technical documentation, User Requirement Specifications (URS), Design Qualifications (DQ), and Traceability Matrices.
• Ensure compliance with all current regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, etc.).
• Manage deviations, changes, and CAPA investigations related to validated systems.
• Collaborate with QA, IT, Engineering, Manufacturing, and project management teams to deliver project milestones.
• Support audits and inspections as subject matter expert for CSV-related topics.
• Maintain and update validation schedules and complete all documentation in accordance with established procedures.

Required Qualifications & Experience:

• Bachelor’s Degree in Engineering, Computer Science, Life Sciences or related discipline.
• 3+ years’ experience in a Computer System Validation role within the pharmaceutical, biotech, or medical device sector.
• Thorough knowledge of GxP regulations and validation guidelines (FDA, EMA, ICH, etc.).
• Experience with automation/IT systems such as PLC, SCADA, MES, LIMS, or DCS is an advantage.
• Strong written and verbal communication skills; ability to explain complex validation topics to technical and non-technical stakeholders.
• Demonstrated problem-solving ability, attention to detail, and commitment to documentation excellence.

Desirable Skills:

• Familiarity with Data Integrity requirements and Data Lifecycle Management.
• Hands-on experience with validation of laboratory, manufacturing or QA systems.
• Project management or leadership experience is a plus.