Validation (CSV) Engineer | Life Sciences
Capgemini
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.
Job Description
As a Computerized System Validation Engineer, you will play a crucial role in ensuring that all computerized systems related to Good Manufacturing Practices (GMP) are validated and function as intended.
Depending on your project, your role will involve:
- Writing and reviewing validation plans (VP) and validation summary reports (VSR).
- Reviewing and approving design documentation to ensure alignment with system requirements and GMP guidelines.
- Writing and reviewing qualification protocols and reports (IQ/OQ & PQ).
- Monitoring the execution of qualification and validation activities.
Your Profile
As an engineer at Capgemini Engineering, you possess the following skills:
- Master's degree in engineering (or equivalent experience).
- Experience with GMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 Annex 11, 21 CFR Part 11, etc.).
- Experience with validation practices and guidelines (V-cycle, ICH, ASTM E2500, etc.).
- Proficiency in English and French.
- Relevant experience in the pharmaceutical industry is a plus.
Capgemini is 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 fuelled 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.