Senior CSV Consultant - ERP & Life Sciences

Rephine; Ibiza; Híbrido; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

Hybrid work model

Global exposure

Career growth

Descripción de la vacante

Rephine seeks a CSV L2 Consultant to lead ERP and other computerized system validations (IQ, OQ, PQ) in regulated environments. You will deliver high-impact validation projects, ensuring compliance and quality across the lifecycle, with international project exposure across Spain, Europe, and China.

Ideal candidates will have a Bachelor’s degree in Chemistry or Engineering, strong multitasking ability, fluency in Spanish and English, and willingness to travel by car for client sites.

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 by car due to on-site client visits.

Responsabilidades

• Lead CSV projects: validate ERP and other critical computerized systems (IQ/OQ/PQ) and prepare key documentation (VMP, URS, SOPs).
• Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines.
• Assess ERP, eDMS, eQMS, LIMS, and other systems for regulatory readiness and efficiency.
• Perform supplier audits and compliance checks across multiple regulatory environments.
• Engage in international projects across Spain, Europe, and China and represent Rephine on-site.

Conocimientos

Multitasking

Communication

Travel by car

Educación

Bachelor's degree in Chemistry or Engineering

Descripción del empleo

Rephine seeks a CSV L2 Consultant to lead ERP and other computerized system validations (IQ, OQ, PQ) in regulated environments. You will deliver high-impact validation projects, ensuring compliance and quality across the lifecycle, with international project exposure across Spain, Europe, and China.

Ideal candidates will have a Bachelor’s degree in Chemistry or Engineering, strong multitasking ability, fluency in Spanish and English, and willingness to travel by car for client sites.