CSV Engineer: Medical Device Validation Lead

CREGG; Galway; On-site; EUR 60,000 - 90,000; Full time

Job summary

CREGG in Galway is seeking an experienced CSV Engineer to join a leading medical device organisation. The role focuses on Computer System Validation, software validation and quality assurance within a regulated environment.

You will lead validation activities across CSV processes, develop and execute validation protocols, and contribute to audits and continuous improvement of CSV/CQV procedures.

Qualifications

• 5+ years' experience in Computer System Validation, CQV, software validation or related validation/quality engineering role.
• Proven experience in medical device industry or highly regulated manufacturing.
• Strong knowledge of CSV and software validation methodologies.
• Experience with IQ/OQ/PQ and validation lifecycle activities.
• Experience developing validation protocols, reports and supporting documentation.
• Knowledge of FDA and EU regulatory requirements for medical devices.

Responsibilities

• Lead and support CSV activities across regulated systems and software applications.
• Prepare and review URS, functional specs, risk assessments, validation plans and traceability matrices.
• Develop and execute software validation protocols with proper documentation.
• Perform risk-based validation assessments for computerized systems.
• Support validation and implementation of GxP and quality-critical systems in manufacturing.
• Ensure compliance with FDA, EU and GxP data integrity principles.
• Manage change controls, deviations, CAPAs and non-conformances for validated systems.
• Collaborate with Quality, IT, Engineering, Manufacturing, Automation and Operations teams.
• Support system upgrades, migrations, integrations and new implementations while maintaining validated state.
• Participate in audits, providing validation documentation and technical support.

Skills

CSV expertise

Software validation

Quality assurance

Regulatory compliance

Documentation skills

Risk-based validation

Cross-functional collaboration

Analytical thinking

Education

Engineering/CS/IT degree

Job description

CREGG in Galway is seeking an experienced CSV Engineer to join a leading medical device organisation. The role focuses on Computer System Validation, software validation and quality assurance within a regulated environment.

You will lead validation activities across CSV processes, develop and execute validation protocols, and contribute to audits and continuous improvement of CSV/CQV procedures.