Computer System Validation
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Location: Barcelona area, Spain (Hybrid)
Presente su candidatura después de leer los siguientes requisitos de habilidades y cualificaciones para este puesto.
Start Date: January 2027
About the RoleWe 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.
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.
- 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.
- 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.
- 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. xqbhyrx
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
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