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CSV Consultant

  • Job
    Full-time
    Junior, Mid & Senior Level
  • Science
    IT & Cybersecurity

AI generated summary

  • You need a degree in biomedical engineering, pharma, IT, or related fields, 2-5 years of CSV experience, strong GxP knowledge, and solid English communication skills (B2+).
  • You will support CSV processes, advise on regulatory compliance, conduct QA activities, perform end-to-end validation, collaborate with teams, and share knowledge on medical devices.

Requirements

  • Academic degree in biomedical engineering, pharmaceutical sciences, IT or computer science or related fields;
  • Previous experience in computerized system validation – CSV, ideally 2 to 5 years;
  • Strong knowledge of GxP regulations and guidelines;
  • Solid verbal and written communication skills in English (at least B2).

Responsibilities

  • Perform as a CSV engineer supporting computerized system validation and IT qualification of applications and software;
  • Anticipate and advise about GxP-regulated and regulatory compliance computerized validation processes needs based on each system specifications;
  • Perform QA activities supporting Medical Devices software development projects;
  • Perform end-to end validation to verify software (validation planning, test protocols and reports, risk assessments);
  • Work within a team with specific roles following regulations and guidelines interacting with other teams and stakeholders;
  • Share knowledge about computerized system validation and medical devices.

FAQs

What is the primary responsibility of a CSV Consultant at Capgemini Engineering?

The primary responsibility includes supporting computerized system validation and IT qualification of applications and software, performing QA activities for Medical Devices software development projects, and ensuring compliance with GxP regulations and guidelines.

What qualifications are required for this position?

An academic degree in biomedical engineering, pharmaceutical sciences, IT, computer science, or related fields is required, along with 2 to 5 years of experience in computerized system validation.

Where is this position located?

This position is open for Lisbon, Porto, and Fundão.

What knowledge is essential for a CSV Consultant in this role?

Strong knowledge of GxP regulations and guidelines is essential for this role.

What language skills are required for this job?

Solid verbal and written communication skills in English are required, with a minimum proficiency level of B2.

Is experience in the medical device industry important for this role?

Yes, previous experience in computerized system validation, particularly in medical devices software development projects, is important.

Will I be working alone or in a team?

You will be working within a team, collaborating with specific roles and interacting with other teams and stakeholders.

What kind of work culture does Capgemini Engineering promote?

Capgemini Engineering promotes a culture centered on embracing a growth mindset, diversity, inclusion, and inspiring excellence.

Capgemini Engineering, the leader in engineering and R&D services, helps clients unleash their R&D potential.

Technology
Industry
10,001+
Employees

Mission & Purpose

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has 60,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet. Capgemini Engineering is an integral part of the Capgemini Group, a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.