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

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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-going 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.

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