Esta oferta de trabajo no está disponible en tu país.
Computer System Validation Senior Consultant
RephineCatalonia, Catalonia, SPAINHace más de 30 días
Descripción del trabajoWork 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. Provide expert assessments of compliance risks and propose actionable solutions. 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. Maintain clear communication and provide regular updates on progress to stakeholders. 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. 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? 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.
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, 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 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. Your key responsibilities will include :
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., VMP, URS, IQ, OQ, PQ).
- Ensure strict adherence to industry regulations, including EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines.
Exploring Advanced Industry Systems :
Auditing and Compliance Assessments :
Engaging in International Projects :
Meeting Deadlines and Driving Client Success :
What You Bring :
Is This Role for You?
Ask yourself :
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 :
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?
Visit our career site to learn more and apply in English.
Crear una alerta de empleo para esta búsqueda
Senior Consultant • Catalonia, Catalonia, SPAIN
Ofertas relacionadas
- Oferta promocionada
Computer System Validation Senior Consultant
RephineCatalonia, España 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...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Senior Verification Engineer
microTECH Global LTDCatalonia, Spain We have had a very exciting opportunity for a Senior Verification Engineer in Barcelona, Spain.Role : Senior Verification Engineer.
European provider of advanced RISC-V IP cores, specializing in high...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Senior Systems Integration Engineer
IC ResourcesCatalonia, Spain A Senior Systems Integration Engineer is sought by this leading developer of full-stack computer solutions which integrate hardware, software and systems aimed at HPC and AI applications.Working fr...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
System-on-Chip Design Engineer
BeagleCatalonia, Spain We are seeking a SoC Top Design and Integration Lead with a strong passion for microprocessor architecture.In this role, you will lead the SoC Top Team, collaborating closely with highly skilled en...Mostrar másÚltima actualización: hace 15 días
- Oferta promocionada
Senior HW Architect - AI HW Accelerators
IC ResourcesCatalonia, España Working for a cutting-edge semiconductor company, I am looking to recruit a Senior Architect, to be responsible for new HW accelerators for AI applications.
Salary available can be circa €100k+ (dep...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Information System Architect
Accenture EspañaCatalonia, Spain Our capabilities span ideation to execution : growth, product and experience design;technology and experience platforms; creative, media and marketing strategy.
and campaign, content and channel orc...Mostrar másÚltima actualización: hace 16 días
- Oferta promocionada
Verification Lead
BeagleCatalonia, Spain The ideal candidate will have extensive expertise in.SystemVerilog, UVM, and advanced verification methodologies.In this role, you will lead the Verification Team, overseeing the validation of comp...Mostrar másÚltima actualización: hace 17 días
- Oferta promocionada
Senior Verification Engineer
Berkeley Square - Talent Specialists in IT & EngineeringCatalonia, Spain Join a fast-growing European semiconductor company developing customizable high-performance.You'll lead RTL verification for next-gen AI / ML compute platforms.
Develop and execute UVM-based testbench...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Senior Design Verification Engineer
IC ResourcesCatalonia, Spain Senior Verification Engineer - RISC-V Start-Up.Are you passionate about microprocessor architecture and ready to make an impact as a Senior Verification Engineer? Interested in a company that’s pus...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
QA Systems Validations
Reig JofreCatalonia, Spain En Reig Jofre estamos buscando a un / a.Su misión principal será la de garantizar una calidad constante en nuestros Sistemas Informáticos y Data Integrity de.
CAPA para evitar su recurrencia.Si te gus...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Técnico / a de Sistemas – 2 posiciones abiertas
SETESCAValls, Catalonia, Spain Desde Setesca Talent, consultora especializada en la selección de perfiles tecnológicos y de alta dirección, estamos gestionando un proceso para una empresa industrial ubicada en la zona de la Conc...Mostrar másÚltima actualización: hace 25 días
- Oferta promocionada
System & Function Owner
INGEDETEC GROUPMartorell, Catalonia, Spain La principal fuente de competitividad que ofrecemos en INGEDETEC la constituye.A lo largo de más de 19 años hemos construido un conjunto dinámico y multidisciplinar.
Nuestros profesionales son princ...Mostrar másÚltima actualización: hace 17 días
- Oferta promocionada
System Verification Engineer
BeagleCatalonia, Spain ROLE : Coherency Verification Engineer.We are seeking a Coherency Verification Engineer with a strong passion for microprocessor architecture.
You will join the Verification Team and play a key role ...Mostrar másÚltima actualización: hace 15 días
- Oferta promocionada
Senior Verification Engineer - UVM / SystemVerilog / Python / Perl / Bash / TCL
European Tech RecruitCatalonia, Spain Verification Engineer - UVM / SystemVerilog / Python / Perl / Bash / TCL.Are you a Mid to Senior level Senior Verification Engineer looking for you next challenge?.
Have experience with SystemVerilo...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Senior Manager Business Applications - SAP Data Migration
SiegfriedBarberà del Vallès, Catalonia, Spain The Siegfried Group is a global life science company with a network of 13 sites in Europe, the USA and Asia.Siegfried offers contract development and manufacturing of active pharmaceutical ingredie...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Senior Functional Consultant
nformalCatalonia, Spain AI technology to our clients based on our principle : a friendly, straightforward, and honest approach that efficiently achieves results.
Drive discovery, demo, and design sessions with the customer’...Mostrar másÚltima actualización: hace 14 días
- Oferta promocionada
IT CSV Consultant (Pharma)
Amaris ConsultingCatalonia, Spain Take your career to the next level with Amaris Consulting as a CSV Consultant (Pharma)!.Become part of an international team, thrive in a global group with €800M turnover and 1,000+ clients worldwi...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
VALIDATION TECHNICIAN
Paul MarlexTerrassa, Catalonia, Spain Desde Paul Marlex estamos colaborando con una de las empresas más punteras en su sector especializada el desarrollo de proyectos de ingeniería y construcción, equipos de proceso integrados y consul...Mostrar másÚltima actualización: hace 5 días
- Oferta promocionada
Solution Architect - PREFAB DATA CENTERS
Schneider ElectricSant Boi de Llobregat, Catalonia, Spain Schneider Electric creates connected technologies that reshape industries, transform cities and enrich lives.Our 135,000+ employees thrive in more than 100 countries.
From the simplest of switches t...Mostrar másÚltima actualización: hace 25 días
- Oferta promocionada
Consultor / a en Sistemas Informáticos Health Cataluña - LIS
NTT DATA Europe & LatamCatalonia, España Tienes experiencia en consultoría tecnológica y te apasiona el sector salud? ¡NTT DATA te está buscando!.En NTT DATA somos reconocidos como uno de los mejores lugares para trabajar en España por 10...Mostrar másÚltima actualización: hace 19 días