Validation Consultant for Data | Pharma - Hybrid

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, we support the Pharmaceutical, Biotech, and Medical Device supply chains globally.

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.

As a

CSV Senior Consultant

, you will take the lead in delivering impactful projects in compliance and validation, contributing to some of the most innovative areas in the industry. Driving Excellence in CSV Projects: Participate in and oversee projects involving the validation of computerized systems across the project lifecycle, including the preparation of critical documentation (e.g., Ensure strict adherence to industry regulations, including

EU GMP Annex 11 ,

FDA 21 CFR Part 11 ,

GAMP 5 , and

Data Integrity

guidelines. Work with and gain exposure to widely used systems, including

ERPs

,

eDMS

,

eQMS

,

LIMS

, laboratory systems,

SCADAs

,

EBRs

, pharmacovigilance, and maintenance systems. Assess system compliance with global standards to ensure efficiency and regulatory readiness. Perform audits of software suppliers to verify adherence to Annex 11, 21 CFR Part 11, and other regulatory frameworks. Engaging in International Projects: Contribute to projects across

Spain

,

Europe

, and

China

, bringing your expertise to clients in diverse regulatory environments. Represent Rephine’s values while working on-site with clients, ensuring seamless collaboration and delivering quality results. Manage project timelines, ensuring deliverables like documentation and test execution are completed as agreed with the client. 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.

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. 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. Visit our career site to learn more and apply in English.