Hybrid Junior CSV Technician – ERP Validation

Rephine; Arbo; Híbrido; EUR 55.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Flexible hours

Shorter Fridays

Descripción de la vacante

Rephine, headquartered with offices in Barcelona, seeks a Computer System Validation Senior Consultant to lead ERP and related system validations in regulated environments. You will operate as CSV L2 Consultant delivering high-impact validation projects across ERP systems and other critical computerized systems.

You will collaborate on international projects spanning Spain, Europe, and China, ensuring compliance with EU GMP Annex 11, FDA 21 CFR Part 11, and data integrity standards while

Formación

• Bachelor's degree in Chemistry or Engineering.
• Solid experience in the pharmaceutical industry, GxP compliance, and computerized systems validation.
• Fluency in Spanish and English, with excellent communication skills.
• Willingness to travel and client-site presence as required.

Responsabilidades

• Lead CSV projects: validate ERP and other computerised systems (IQ/OQ/PQ) with critical documentation.
• Perform supplier audits and compliance checks per Annex 11 and 21 CFR Part 11.
• Engage with international clients across Spain, Europe, and China.
• Deliver projects on time, manage documentation, and execute tests.
• Support digital transformation to improve manufacturing and quality processes.

Conocimientos

Multitasking

Spanish language

English language

Educación

Bachelor's degree in Chemistry or Engineering

Herramientas

ERP systems

eDMS

eQMS

LIMS

SCADA

EBRs

Pharmacovigilance

Descripción del empleo

Rephine, headquartered with offices in Barcelona, seeks a Computer System Validation Senior Consultant to lead ERP and related system validations in regulated environments. You will operate as CSV L2 Consultant delivering high-impact validation projects across ERP systems and other critical computerized systems.

You will collaborate on international projects spanning Spain, Europe, and China, ensuring compliance with EU GMP Annex 11, FDA 21 CFR Part 11, and data integrity standards while