Hybrid CSV Specialist – Pharma Validation & Compliance

Oxford Global Resources; Barcelona; Híbrido; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Oxford Global Resources in Barcelona is seeking an experienced Computerized Systems Validation (CSV) Specialist for a hybrid pharmaceutical environment. You will lead validation projects across manufacturing, quality, and laboratory systems, ensuring GxP compliance and inspection readiness throughout their lifecycle.

The role requires deep knowledge of GAMP 5, Annex 11, and ALCOA+ data integrity, plus experience with MES/LIMS/QMS/ERP/SCADA and risk-based validation methods.

Formación

• Experience in Computerized Systems Validation within regulated environments (pharma/biotech/medical devices).
• Strong knowledge of GAMP 5, EU GMP Annex 11, Data Integrity (ALCOA+), and 21 CFR Part 11.
• Experience validating GxP systems (MES/LIMS/QMS/ERP/SCADA) and manufacturing applications.
• Risk-based validation methodologies understandings.
• Excellent stakeholder management and communication skills.
• Ability to work across multidisciplinary teams.

Responsabilidades

• Lead validation projects for computerized systems from implementation through retirement.
• Define validation strategies using risk-based approaches aligned with GAMP 5.
• Develop and review validation documentation (URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrices, Validation Summary Reports).
• Support system upgrades and periodic reviews, infrastructure changes.
• Ensure GMP, Data Integrity, Annex 11, and 21 CFR Part 11 compliance.
• Participate in audits and inspections as CSV SME.
• Manage deviations, CAPAs, and change controls.
• Collaborate with Quality, IT, Manufacturing, Engineering, Laboratory and Regulatory teams.
• Drive continuous improvement and digital transformation initiatives.

Conocimientos

GAMP 5

EU GMP Annex 11

Data Integrity

21 CFR Part 11

Stakeholder management

Communication

Cross-functional teams

GxP systems validation

MES

LIMS

QMS

ERP

SCADA

Descripción del empleo

Oxford Global Resources in Barcelona is seeking an experienced Computerized Systems Validation (CSV) Specialist for a hybrid pharmaceutical environment. You will lead validation projects across manufacturing, quality, and laboratory systems, ensuring GxP compliance and inspection readiness throughout their lifecycle.

The role requires deep knowledge of GAMP 5, Annex 11, and ALCOA+ data integrity, plus experience with MES/LIMS/QMS/ERP/SCADA and risk-based validation methods.