Computer System Validation (CSV) Specialist & Site Data Integrity Lead (Arklow, Wicklow, IE, Y14E284)

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

The Computer System Validation (CSV) Specialist is responsible for ensuring that all GxP-relevant computerised systems are validated, compliant, and maintained in accordance with cGMP requirements.

This role combines regulatory compliance leadership (approximately 70%) with project-based validation support (approximately 30%), ensuring validation principles are embedded throughout the system lifecycle and that systems remain in a continuous state of compliance.

Key responsibilities will include, but are not limited to:

Data Integrity

• Responsible for ensuring compliance with Data Integrity requirements across site.
• Co-ordinate and collaborate with data integrity SMEs on site to ensure gaps are identified and addressed as required
• Maintain data integrity risk assessment and ensure KPI’s are developed and maintained to ensure on-ongoing maintenance of data integrity risk management.
• Act as data integrity SME for the site
• Owner of Data Integrity Policy for the site
• Ensure strong data integrity controls are in place across systems and processes
• Complete Data Integrity Training with relevant groups as required

Operational:

1. Regulatory Compliance & CSV Governance (70%)

• Act as Subject Matter Expert (SME) for computer system validation, regulatory compliance, and data integrity.
• Ensure all GxP systems are validated and maintained in compliance with applicable regulatory requirements
• Maintain systems in a validated state through:
  • Change control management
  • Periodic review processes
  • Lifecycle management activities
• Develop and maintain validation documentation, including:
  • Validation Master Plans
  • Validation protocols and reports
  • SOPs/WISOPs defining validation strategy and lifecycle processes
• Lead and support audit and inspection readiness activities, including preparation for regulatory inspections
• Perform and facilitate risk assessments to ensure appropriate validation efforts are applied
• Coordinate:
  • Change controls
  • Quality documentation
  • Compliance-related activities within the department

2. Project Validation Support (30%)

• Provide validation oversight for system implementations, upgrades, and digital transformation initiatives
• Ensure validation activities are incorporated from project initiation ("validation by design")
• Develop and execute:
  • Validation plans
  • Test protocols (IQ/OQ/PQ)
  • Traceability documentation
• Support system qualification and ensure all deliverables meet compliance standards.
• Collaborate with cross-functional teams (IT, Quality, Business) to ensure successful project delivery
• Support transition of systems into operational validated state following implementation
• Collaborate with the Quality Validation team to complete validation deliverables

Requirements for the position:

Essential:

• Third-level qualification in Information Technology, Engineering, or a Scientific/Quality discipline.
• Demonstrated experience in Computer System Validation in a regulated environment
• Strong knowledge of:
  • Regulatory compliance requirements (including US FDA expectations)
  • GxP systems and validation lifecycle
  • Risk-based validation principles.
• Experience preparing and maintaining validation documentation

Desirable:

• Experience supporting regulatory inspections or audits
• Familiarity with GAMP 5 principles
• Experience with enterprise systems (e.g. ERP, MES, LIMS)
• Experience working on digital transformation projects

Additional Requirements / Attributes

• Strong analytical and problem-solving skills
• Excellent technical writing and documentation capability
• Ability to interpret regulatory requirements and translate into compliant practices
• Effective stakeholder engagement and cross-functional collaboration
• High attention to detail
• Strong organisational and prioritisation skills

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.