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 General 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.

📌 Computer System Validation (España)
🏢 Oxford Global Resources
📍 España