Computer System Validation Specialist & Site Data Integrity Lead

Servier (Ireland) Industries Ltd.; Bray (OK); Hybrid; USD 87,000 - 127,000; Full time

Benefits offered by this job

Health insurance

Flexitime

Hybrid pension

Job summary

Servier (Ireland) Industries Ltd. seeks a Computer System Validation (CSV) Specialist & Site Data Integrity Lead to ensure GxP systems are validated and maintained in a compliant state across the site.

This role blends regulatory compliance leadership (roughly 70%) with project-based validation support (about 30%), embedding validation principles through the lifecycle and maintaining continuous data integrity.

Qualifications

• 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.

Responsibilities

• Regulatory compliance & CSV governance across the site; act as SME for data integrity.
• Lead risk assessments and maintain data integrity risk management KPIs.
• Coordinate change controls and ensure validation documentation (VMPs, protocols, reports).
• Prepare for regulatory inspections and support audit readiness.
• Collaborate with IT, Quality and Business teams on validation plans and traceability (IQ/OQ/PQ).

Skills

Analytical thinking

Data integrity

Regulatory compliance

Documentation/writing

Stakeholder engagement

Education

Bachelor's degree in IT/Engineering/Quality

Tools

ERP

MES

LIMS

GAMP 5 familiarity

Job description

Job Description

Computer System Validation (CSV) Specialist &Site Data Integrity Lead 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 KPIs 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. 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. 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

At Servier, we are committed to creating a workplace where everyone feels valued, respected and encouraged to bring their whole selves to work. And it starts herewe welcome applicants from all backgrounds, experiences and perspectives. Applicants who may require assistance or reasonable accommodations for any part of the application or interview process, please let us know.

2 Year Fixed Term Contract

• health insurance
• Flexitime
• Hybrid #Pension TPBN1_IJ