Computer System Validation Senior

hace 1 mes


Barcelona, España Montreal Associates A tiempo completo

Are you passionate about learning? Do you want to make a difference by managing Multi-Projects Consulting?

Are you ready to work in Global multisite company?

We are looking for a Computer System Validation Senior Consultant to join our Barcelona team.

Your Challenge (Describe the missions): Our team of highly experienced, top-level consultants carry out key projects for companies around the world in the areas of:

* GxP readiness. Assessing and targeting improvements while ensuring there are no gaps in quality or compliance across all phases of the product development and manufacturing lifecycle.

* Design Review of new facilities, commissioning and qualification of equipment and utilities are also key aspects of this service.

* Digital transformation. Assisting on how to redesign and optimize manufacturing quality processes to take advantage of the latest technology (cloud-based solutions, IoT or AI/machine learning), validate those systems and ensure data integrity.

* Medical Devices. Latest regulatory framework and manufacturing requirements specific to smart/digital devices as well as health tracking apps.

* Quality management System (QMS). Advisory service helping our customers to achieve a systematic approach to Quality design and maintenance, and optimized business processes. We also deploy the TrackWise Digital Quality Management Software. Your main responsibilities: * Reporting directly to CSV Area Manager:

* Collaboration on GxP compliance projects, especially in Computerized Systems Validation projects * Active role in the delivery of Validation of Computerized Systems related projects including customer service, defining project approach and guiding the execution of the different validation activities, leading follow-up meetings, writing and reviewing of validation deliverables , supporting test execution and reporting.

This Job is for you IF:

* Bachelor's degree in chemistry or engineering.

* Experience working in pharmaceutical environment and knowledge of the pharmaceutical and chemical business, manufacturing, and quality processes (GxP compliance, validation, and quality systems management, GMP Annex 11, 21CFR part 11, Data Integrity Principles, GAMP 5, ...)

. * Experience in computerized systems validation (ERP, eDMS, eQMS, LIMS, Laboratory systems, EBRMES, SCADAs, …)

* Experience in data integrity assessment/remediation projects.

* Experience in change or incident management regarding computerized systems

* Experience in IT infrastructure projects and Agile methodologies is a plus.

We offer:

* Benefits: Competitive salary according to experience, additional extra-legal vacation days, and other competitive benefits.

* Teamwork: highly qualified staff with numerous years of experience, always available to help. * Flexibility: Hybrid mode, autonomy, reduced workday each Friday, flexible hours.

* Global Company: Growing global company and multicultural team.

* Learning program: Training and development program

* Continuous training and English and Chinese lessons

* Occasionally teambuilding, social events

* Excellent culture and work environment.

Young and enthusiastic team of consultants.

Montreal Associates is acting as an Employment Agency in relation to this vacancy.



  • Barcelona, España Oxford Global Resources A tiempo completo

    **JUNOR AUTOMOTIVE SYSTEM VALIDATION ENGINEER**: - Location: Barcelona, Spain - Contact: Nina Salmito - Job type: Contract - Contact phone: 0034 93 522 23 38 - Industry: Software Desde Oxford Global Resources buscamos un Junior Automotive System Validation Engineer para llevar a cabo la validación a nível de sistema del producto proporcionando...

  • Validation Manager

    hace 4 semanas


    Barcelona, España Ambit BST A tiempo completo

    We are looking for a _Validation Manager_ who will offer service to a multinational pharmaceutical company inside the Factory Integration department. **TASKS**: - Ensures that appropriate validation activities take place in order to comply with the validation planning and applicable company prior to operation of the system. - Ensures that all...


  • Barcelona, España amaris A tiempo completo

    Job description Take your career to the next level with Amaris Consulting as an IT Quality Computer System Assurance in Barcelona. Become part of an international team, thrive in a global group with €800M turnover and 1,000+ clients worldwide, and an agile environment. Join Amaris Consulting, where you can develop your potential and make a difference...


  • Barcelona, España Amaris Consulting A tiempo completo

    **Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60...


  • Barcelona, España Oxigent A tiempo completo

    ¿Te interesaría continuar desarrollándote como System Validation Engineer manejando CANoe y protocolos de comunicación LIN dentro del sector automoción? Desde Oxigent Technologies, consultora tecnológica, seleccionamos un/a SYSTEM VALIDATION ENGINEER para participar de proyectos de validación de sistemas embebidos dentro del sector automoción y...

  • Validation Manager

    hace 4 horas


    Barcelona, España Next-Link A tiempo completo

    We are seeking a highly motivated and experienced Validation Manager to join our team, providing expert services to a leading pharmaceutical client. Main tasks and responsibilities: Develop and document validation strategies for complex projects, considering both business needs and regulatory requirements (GxP, FDA, etc.). Define and implement validation...

  • Validation Manager

    hace 4 horas


    Barcelona, España Next-Link A tiempo completo

    Job Description We are seeking a highly motivated and experienced Validation Manager to join our team, providing expert services to a leading pharmaceutical client. Main tasks and responsibilities: Develop and document validation strategies for complex projects, considering both business needs and regulatory requirements (GxP, FDA, etc.). Define and...

  • Validation Manager

    hace 7 días


    Barcelona, España Ambit BST A tiempo completo

    **WHAT WILL BE YOUR MISSION**: - Ensures appropriate validation activities take place in order to comply with the validation planning and applicable prior to operation of the system. - Ensures that all system-specific SOP's and SLC documentation are in place prior operation phase. - Ensures that the validated status of the system is maintained after the...


  • Barcelona, España Oxigent A tiempo completo

    ¿Te interesaría seguir desarrollándote como **Automotive System Validation Engineer **en una **multinacional dedicada al sector industrial?** Desde **Oxigent Technologies** seleccionamos **un/a Ingeniero/a de validación de sistemas **para participar en un proyecto de automoción **ubicado en Barcelona y alrededores.** **¿Cuáles serán tus funciones...

  • System Architect

    hace 3 días


    Barcelona, España Expert Executive Recruiters A tiempo completo

    Our Client is developing the next generation of high-performance e-powertrain systems that will change the electric vehicles market. We are seeking an experienced System Architect/Engineer to join their growing team in Barcelona.ResponsibilitesSystem engineering and architecture of innovative automotive systemsTranslate customer needs into system...

  • System Engineer

    hace 4 semanas


    Barcelona, España GE Renewable Energy A tiempo completo

    **Job Description Summary**: The System engineer will be leading all aspects of the engineering efforts to meet product targets by ensuring alignment within engineering disciplines, negotiating, collaborating and influencing both internally and externally with our clients. In your role of System Engineer you will be the main owner for the product...


  • Barcelona, España GE Renewable Energy A tiempo completo

    **Job Description Summary**: Join our team as the Senior Systems Engineer for our Offshore Wind product range. You will be leading all aspects of the engineering efforts to meet requirements by ensuring alignment within engineering disciplines, negotiating, collaborating and influencing both internally and externally with our clients. In your role a Senior...


  • Barcelona, España Oracle A tiempo completo

    Senior System Administrator-230003RB **Applicants are required to read, write, and speak the following languages***: English **Preferred Qualifications** This position is for a System Administrator in the Oracle NetSuite OpenAir Operations group focusing on providing high level System support in areas of monitoring, backups, capacity planning, high...


  • Barcelona, España Ambit BST A tiempo completo

    Te invitamos a unirte a nuestro equipo de Pharma&Biotech como **Senior Validation Consultant. **En este rol, tendrás la oportunidad de sumergirte en proyectos, auditorías y formaciones extremadamente interesantes. Si buscas contribuir con tu experiência en un equipo innovador y participar en iniciativas que marquen la diferencia, esta oportunidad es para...

  • Senior System Engineering

    hace 4 semanas


    Barcelona, España NTT DATA A tiempo completo

    El área de inCar de NTT DATA se centra en la transformación digital de I+D en el sector automotriz desde el desde el desarrollo de software embedded, HMI y System Engineering. Buscamos reforzar nuestro equipo funcional con profesionales experimentados en el ámbito de System Engineering para el sector de Automoción. Tu misión es, capturar y analizar...


  • Barcelona, España Ntt Data A tiempo completo

    Job Description El área de inCar de NTT DATA se centra en la transformación digital de I+D en el sector automotriz desde el desde el desarrollo de software embedded, HMI y System Engineering.Buscamos reforzar nuestro equipo funcional con profesionales experimentados en el ámbito de System Engineering para el sector de Automoción. Tu misión es,...


  • Barcelona, España NTT DATA A tiempo completo

    Job Description El área de inCar de NTT DATA se centra en la transformación digital de I+D en el sector automotriz desde el desde el desarrollo de software embedded, HMI y System Engineering.Buscamos reforzar nuestro equipo funcional con profesionales experimentados en el ámbito de System Engineering para el sector de Automoción. Tu misión es,...

  • IT System Administrator

    hace 4 semanas


    Barcelona, España Michael Page A tiempo completo

    ¿Dónde vas a trabajar? International manufacturing company. Present in more than 10 cities in the world. ¿Qué harás en tu nuevo puesto? To be successful as a system administrator, you should have an excellent ability to solve problems using your in-depth understanding of information systems and computing solutions. The best system administrator will...

  • Computer Technician

    hace 4 semanas


    Barcelona, España SCI – Serviclients Informatica A tiempo completo

    Barcelona - Posted on 06/15/2023 **No. of vacancies**: **1** **functions** - Respond to user requests and record them - Generate solutions for those problems reported by users - Technical assistance and solution of hardware and software operating problems - Deployment of computer equipment - Performing preventive and corrective maintenance - Track tickets...


  • Barcelona, España David Kennedy Recruitment A tiempo completo

    David Kennedy Recruitment has partnered with a leading BPO company which supports top tech brands in providing exceptional customer care. Together, we’re looking for a Spanish and English-speaking Senior System Administrator (L3) to join their office in Barcelona. Position: Senior System Administrator Location: Barcelona, Spain Employment type:...