Computer System Validation (CSV)

Oxford Global Resources; Barcelona; Hybrid; EUR 60,000 - 95,000; Full time

Job summary

Oxford Global Resources Life Sciences is seeking a CSV specialist with 2+ years of experience to join our client in the Barcelona area on a hybrid basis. You will drive validation activities for GxP-regulated systems within the IT organization.

You will author validation plans, IQ/OQ/PQ protocols and traceability matrices, execute testing, manage change controls, and support regulatory inspections. This is a long-term opportunity with potential internalization within the client.

Qualifications

• Experience in Computer System Validation (CSV) within a pharmaceutical, biotech, or regulated life sciences environment.
• Knowledge of GxP regulations and computerized system compliance requirements.
• Experience with validation lifecycle management.
• Experience creating and executing validation protocols and documentation.
• Knowledge of Change Control, CAPA, and Risk Management processes.
• Strong stakeholder management and communication skills.

Responsibilities

• Lead CSV activities for GxP-regulated systems.
• Ensure projects are delivered in a compliant and validated state.
• Author and execute validation documentation (Plans, IQ/OQ/PQ, Traceability Matrices, Validation Reports).
• Execute and coordinate testing activities.
• Manage change controls and validation lifecycle for 20+ GxP systems.
• Collaborate with Quality Assurance, IT, Engineering, and business stakeholders.
• Support regulatory inspections and audit readiness.
• Provide guidance on CSV and Data Integrity best practices.

Skills

CSV

GxP regulations

Validation lifecycle

Validation documentation

Change Control

Data Integrity

Stakeholder management

Communication skills

Tools

PAS-X

Veeva

LIMS

MES

ERP

Job description

Location: Barcelona area, Spain (Hybrid)

Start Date: January 2027

About the Role

We are looking for 2+ year Computer System Validation (CSV) to join a leading global pharmaceutical company. This position sits within the IT organization and plays a key role in ensuring GxP-regulated systems and projects are delivered in a validated state.

The successful candidate will work closely with project teams, quality stakeholders, and IT leadership to drive validation activities across critical systems and strategic digital transformation initiatives.

This is a long-term opportunity at Oxford Global Resources Life Sciences with the potential to transition into a permanent internal role within our client.

Responsibilities

• Lead Computer System Validation activities for GxP-regulated systems.
• Ensure projects are delivered in a compliant and validated state.
• Author and execute validation documentation, including:
• Validation Plans
• IQ/OQ/PQ Protocols
• Traceability Matrices
• Validation Reports
• Execute and coordinate testing activities.
• Manage change controls and validation lifecycle activities for more than 20 GxP systems.
• Conduct periodic reviews and system assessments.
• Collaborate with Quality Assurance, IT, Engineering, and business stakeholders.
• Support regulatory inspections and audit readiness activities.
• Provide guidance on CSV and Data Integrity best practices.

Key Projects

The role will support multiple high-impact initiatives, including:

• PAS-X implementation and migration projects
• LIMS implementations and enhancements
• Additional regulated IT and digital transformation projects within Manufacturing and Quality environments.

Requirements

Must Have

• Experience in Computer System Validation (CSV) within a pharmaceutical, biotech, or regulated life sciences environment.
• Knowledge of GxP regulations and computerized system compliance requirements.
• Experience with validation lifecycle management.
• Experience creating and executing validation protocols and documentation.
• Knowledge of Change Control, CAPA, and Risk Management processes.
• Strong stakeholder management and communication skills.

Nice to Have

• Experience with PAS-X, Veeva, LIMS, MES, ERP, or other validated systems.
• Familiarity with Annex 11, GAMP 5, FDA 21 CFR Part 11, and Data Integrity requirements.
• Project leadership experience.

What We Offer

• Long-term strategic assignment within a leading pharmaceutical company.
• Opportunity to work on large-scale digital transformation initiatives.
• Exposure to multiple regulated systems and business-critical projects.
• Strong career development potential with possible future internalization.
• Collaborative environment with training and support available for high-potential candidates.

Keywords

Computer System Validation | CSV | GxP | GAMP5 | Annex 11 | FDA 21 CFR Part 11 | Veeva | PAS-X | LIMS | Validation Lead | Data Integrity | Pharma | Biotechnology | Life Sciences | Quality Systems | Change Control

This version is optimized for LinkedIn Recruiter and should attract both senior CSV Specialists and Validation Leads.