Senior CSV Lead for GxP Validation (Pharma, Hybrid)

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

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.