CSV Specialist

ACCPRO; Wicklow; On-site; EUR 75,000 - 110,000; Full time

Job summary

ACCPRO is seeking an experienced Computer System Validation (CSV) Specialist & Site Data Integrity Lead to join a regulated GxP environment in Wicklow, Ireland. The role combines CSV, data integrity and regulatory compliance to keep computerised systems validated and in a state of control.

You will act as SME across CSV and GxP, lead data integrity activities, manage validation documentation, and provide oversight for MES/ERP/LIMS projects, audits and inspections.

Qualifications

• Demonstrated experience in Computer System Validation within regulated/GxP environments.
• Strong knowledge of GxP systems and validation lifecycle.
• Experience preparing and maintaining validation documentation.
• Understanding of regulatory requirements including FDA expectations.
• Experience with GAMP 5, MES, ERP or LIMS is desirable.
• Experience supporting audits or digital transformation projects is advantageous.
• Excellent analytical, technical writing and stakeholder management skills.

Responsibilities

• Act as SME for CSV, GxP compliance and Data Integrity across the site.
• Lead Data Integrity activities including risk assessments, KPI development, gap identification and controls.
• Maintain systems in a validated state through change control and lifecycle management.
• Develop and maintain validation documentation including Validation Master Plans, protocols, reports and SOPs/WISOPs.
• Provide validation oversight for MES/system implementations, upgrades and digital transformation projects.
• Develop and execute validation plans, IQ/OQ/PQ protocols and traceability documents.
• Support audits and regulatory inspections and ensure compliance with regulatory requirements.
• Work with IT, Quality, Business and Validation teams to deliver compliant projects.

Skills

CSV expert

Data integrity

GxP compliance

Regulatory compliance

Validation lifecycle

Risk-based validation

Documentation

Stakeholder management

Project coordination

Tools

GAMP 5

MES

ERP

LIMS

Job description

We are seeking an experienced Computer System Validation (CSV) Specialist & Site Data Integrity Lead to join a regulated GxP environment.

This is a key role combining CSV, regulatory compliance, data integrity and project validation, with responsibility for ensuring GxP computerised systems remain validated, compliant and in a continuous state of control.

Key Responsibilities

• Act as SME for Computer System Validation, GxP compliance and Data Integrity across the site.
• Lead Data Integrity activities, including risk assessments, KPI development, gap identification and implementation of effective controls.
• Maintain systems in a validated state through change control, periodic reviews and lifecycle management.
• Develop and maintain validation documentation, including Validation Master Plans, protocols, reports and SOPs/WISOPs.
• Provide validation oversight for MES/system implementations, upgrades and digital transformation projects.
• Develop and execute validation plans, IQ/OQ/PQ protocols and traceability documentation.
• Support audit and regulatory inspection readiness and ensure compliance with applicable regulatory requirements.
• Work closely with IT, Quality, Business and Validation teams to deliver compliant projects and transition systems into operational use.
• Provide training and guidance on Data Integrity and validation requirements.

About You

• Demonstrated experience in Computer System Validation within a regulated/GxP environment.
• Strong knowledge of GxP systems, validation lifecycle and risk-based validation principles.
• Experience preparing and maintaining validation documentation.
• Strong understanding of regulatory compliance requirements, including US FDA expectations.
• Experience with GAMP 5, MES, ERP or LIMS would be highly desirable.
• Experience supporting audits, inspections or digital transformation projects is an advantage.
• Excellent analytical, technical writing, stakeholder management and organisational skills.

This is an excellent opportunity for a CSV professional looking to take ownership across validation, data integrity and regulatory compliance while supporting major systems and digital transformation initiatives.