Join Rephine Barcelona: Leading Life Sciences Quality Worldwide
At Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, and China, India, we support the Pharmaceutical, Biotech, and Medical Device supply chains globally.
Who We're Looking For:
Are you passionate about consulting in the Pharma and Life Sciences sector? Do you thrive in dynamic environments, eager to take on multiple projects and drive real impact? If you're excited by the challenge of enhancing quality and compliance in a global company, we want you as our next Computer System Validation Senior Consultant in Barcelona.
Your Role:
As a CSV L3 Technician , you will take an active role in delivering high-impact validation projects, with a focus on ERP systems and other critical computerized systems in regulated environments. You will be part of innovative projects, ensuring compliance, efficiency, and quality across the lifecycle.
Key Responsibilities:
Manage CSV Projects:
- Take ownership of ERP and other computerized system validations (IQ,



OQ, PQ), preparing and reviewing critical documentation (VMP, URS, SOPs).
- Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines.

ERP & System Expertise:
- Work hands‑on with ERPs, eDMS, eQMS, LIMS, laboratory systems, SCADA, EBRs, pharmacovigilance, and maintenance systems.
- Assess system compliance and performance to optimize regulatory readiness and operational efficiency.

Audits & Compliance Assessments:
- Perform supplier audits and compliance checks, focusing on Annex 11, 21 CFR Part 11, and integral regulations.
- Identify risks, provide actionable recommendations, and ensure corrective measures are implemented.

International Project Engagement:
- Contribute to projects across Spain, Europe, and China, adapting to diverse regulatory environments.
- Represent Rephine on‑site with clients, ensuring seamless collaboration and deliver

📌 Computer System Validation Consultant (España)
🏢 Rephine
📍 España