Computer System Validation (CSV) Engineer
Capgemini EngineeringFunctieomschrijving
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.
Your role
As a Computer System Validation (CSV) Engineer, you will play a key role in ensuring that computerized systems used in regulated environments meet compliance standards and operate as intended. You will collaborate with cross-functional teams to develop and execute validation strategies that align with industry regulations.
In this role you will play a key role in:
- Developing and executing validation protocols in pharmaceutical environments
- Implementing ISPE GAMP5 principles within quality, operational, and project contexts
- Analyzing and validating a wide range of technical systems, including automated systems in regulated environments
- Minimum 3 years experience in validation and qualification in the pharmaceutical industry (FDA, Eudralex, WHO) or equivalent environments (food, cosmetics)
- Strong knowledge of ISPE GAMP5 principles applied to quality, operational and project contexts
- Excellent analytical skills to actively contribute to validation strategies and CSV activities
- Fluency in both French and English (written and spoken)
- Hybrid working: We encourage flexibility when it comes to when and where works gets done. Employees work with their managers to determine an arrangement that works best for their role and personal circumstances.
- Free access to learning platforms: Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more.
- Worldwide Leader of Engineering 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. We help our clients unleashing their R&D potential to develop smart products and services of tomorrow.
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