Senior CSV & Data Integrity Lead (GxP Compliance)

Biopharma Careers; Arklow; On-site; EUR 65,000 - 90,000; Full time

Job summary

Servier Group seeks a Computer System Validation (CSV) Specialist to ensure GxP-compliant computerised systems are validated, compliant and maintained. The role blends regulatory leadership (~70%) with project-based validation support (~30%), embedding validation throughout the system lifecycle and sustaining ongoing compliance.

Key responsibilities include data integrity stewardship, regulatory compliance oversight, documentation development, and coordination of validation activities across IT,

Qualifications

• Requires third-level qualification in IT, Engineering or a scientific/quality discipline.
• Experience in Computer System Validation in a regulated environment.
• Strong knowledge of regulatory requirements (FDA) and GxP lifecycle.

Responsibilities

• Provide SME expertise for CSV governance and regulatory compliance.
• Lead and support validation documentation (VMPs, protocols, reports) and lifecycle activities.
• Coordinate change controls, quality documents and compliance tasks within the department.
• Lead audit and inspection readiness activities and facilitate risk assessments.
• Provide validation oversight for system implementations and digital transformations.

Skills

Analytical skills

Technical writing

Regulatory interpretation

Stakeholder engagement

Attention to detail

Organisational skills

Education

Bachelors or higher in IT/Engineering/Science/Quality

Tools

ERP

MES

LIMS

Job description

Servier Group seeks a Computer System Validation (CSV) Specialist to ensure GxP-compliant computerised systems are validated, compliant and maintained. The role blends regulatory leadership (~70%) with project-based validation support (~30%), embedding validation throughout the system lifecycle and sustaining ongoing compliance.

Key responsibilities include data integrity stewardship, regulatory compliance oversight, documentation development, and coordination of validation activities across IT,