Computer System Validation Consultant - Lleida

Rephine; España; On-site; PHP 3,997,000 - 6,541,000; Full time

Benefits offered by this job

Competitive compensation

Hybrid work model

Global exposure

Dynamic work environment

Growth opportunities

Job summary

Rephine busca un CSV L2 Senior Consultant para Barcelona. Liderarás validaciones de ERP y sistemas críticos en entornos regulados, garantizando documentación (IQ/OQ/PQ) y cumplimiento normativo. Participarás en proyectos internacionales y representarás a Rephine en sitio con clientes.

Se requiere formación en Química o Ingeniería y experiencia en GxP; dominar español e inglés y estar disponible para viajes. Se valora enfoque orientado al cliente y capacidad de gestión de múltiples proyectos.

Qualifications

• Titulación en Química o Ingeniería (B.Sc./Licenciatura).
• Experiencia en industria farmacéutica, GxP y validación de sistemas informáticos.
• Se valora fluidez en español e inglés y capacidad de gestionar múltiples proyectos.
• Se requiere disponibilidad para viajar y trabajar en sitios de cliente.

Responsibilities

• Liderar proyectos CSV (IQ/OQ/PQ) para ERP y otros sistemas computarizados en entornos regulados.
• Asegurar cumplimiento con EU GMP Anexo 11, FDA 21 CFR Part 11, GAMP 5 y directrices de integridad de datos.
• Trabajar con ERP, eDMS, eQMS, LIMS y sistemas de laboratorio; evaluar cumplimiento y desempeño.
• Realizar auditorías de proveedores y evaluaciones de cumplimiento, proponiendo medidas correctivas.
• Contribuir a proyectos internacionales (España, Europa y China) y representar a Rephine in situ.

Skills

Español fluido

Inglés fluido

Conocimientos GxP

Gestión de proyectos

Cumplimiento regulatorio

Education

Titulación en Química o Ingeniería

Tools

ERP systems

eDMS/eQMS

LIMS

Validación IQ/OQ/PQ

Job description

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?

If your answer is "yes" to these questions, then this opportunity at Rephine is your chance to make a significant impact while growing your career in CSV consulting.

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.

Ready to embark on this journey?