Computer System Validation Consultant

Rephine; Valladolid; Híbrido; EUR 42.000 - 56.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Flexible hours

Career growth

Travel opportunities

Descripción de la vacante

Rephine busca un CSV Senior Consultant para Valladolid, con experiencia en ERP y validación de sistemas computarizados en entornos regulados. Se trabajará en proyectos internacionales, asegurando cumplimiento y eficiencia en todo el ciclo de vida de las validaciones.

Se requiere licenciatura en Química o Ingeniería, dominio de español e inglés y disposición para viajar a clientes. Ofrecemos modelo híbrido y proyección de crecimiento profesional dentro de la empresa.

Formación

• Título universitario en Química o Ingenieria.
• Experiencia sólida en la industria farmacéutica, cumplimiento GxP y validación de sistemas computarizados.
• Habilidad para gestionar múltiples proyectos de consultoría y cumplir plazos.
• Fluidez en español e inglés, con excelentes comunicaciones.

Responsabilidades

• Liderar proyectos de validación CSV (ERP y otros sistemas) y preparar/documentar IQ/OQ/PQ, VMP, URS, SOPs.
• Asegurar cumplimiento con EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5 y Data Integrity.
• Realizar auditorías de proveedores y evaluaciones de cumplimiento; identificar riesgos y proponer mejoras.
• Representar a Rephine in situ con clientes y gestionar la entrega de resultados de alta calidad.
• Gestionar plazos y entregables, mantener comunicación con las partes interesadas.

Conocimientos

CSV validation

ERP systems

Regulatory compliance

Documentation

GxP

English and Spanish

Educación

Bachelor’s degree in Chemistry or Engineering

Herramientas

eDMS

eQMS

LIMS

Descripción del empleo

Computer System Validation Consultant Rephine Valladolid, castilla y león, Spain

Descripción del trabajo

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 L2 Consultant, 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:

Lead 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 global 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 delivering high-quality results.

Project Delivery & Client Success:

• Manage timelines and ensure all deliverables, including documentation and test execution, are completed on schedule.
• Maintain clear communication with stakeholders and provide progress updates regularly.

Why This Role Could Excite You:

• Take a leading role in ERP validation projects while expanding your CSV expertise.
• Work with international teams and cutting-edge systems in a fast-paced consulting environment.
• Be recognized as an L2 expert contributing to both client success and Rephine’s high standards.

What You Bring:

• A Bachelor’s degree in Chemistry or Engineering.
• Solid experience in the pharmaceutical industry, GxP compliance, and computerized systems validation.
• Strong multitasking skills and experience in managing multiple consulting projects to meet client needs.
• Fluency in Spanish and English, with excellent communication skills.
• Since client sites are often not easily accessible by public transportation, a valid driver's license and willingness to travel by car are required.

Is This Role for You?

Ask yourself:

• Are you excited about working on-site with clients to tackle their most critical challenges?
• Can you maintain a sense of ownership and connection to the Rephine team, even when managing demanding client-facing responsibilities?
• Do you have the adaptability to move between technical tasks, regulatory compliance, and client interaction with ease?
• Are you ready to learn and grow in a role that exposes you to a wide range of systems and industries?

Why Choose Rephine?

We believe in rewarding talent and commitment with a comprehensive benefits package designed to support your personal and professional growth:

• Competitive Compensation: A salary that reflects your experience, along with additional vacation days and other benefits.
• Work-Life Balance: Take advantage of our hybrid work model, flexible hours, and a shorter workday on Fridays, allowing you to maintain a healthy balance between work and personal life.
• Global Exposure: Work with a multicultural team across multiple countries, providing opportunities to expand your professional network and gain international experience.
• Dynamic Work Environment: Join a young, enthusiastic team where your contributions are valued, and your ideas can shape the future of the company.
• Flexible Salary Options: Benefit from salary sacrifice schemes and more flexibility in managing your compensation package.
• Opportunities for Growth: We provide a nurturing environment where your career can grow beyond expectations. Whether you're looking for new challenges or leadership opportunities, Rephine is committed to your continuous development.
• Drive Digital Transformation: Participate in projects where you can use the latest technologies to optimize manufacturing and quality processes.

For over 20 years, Rephine has been at the forefront of improving manufacturing quality processes for leading Life Sciences companies. We’re evolving rapidly and looking for passionate professionals eager to grow with us.