Computer System Validation (CSV) Engineer | Life Sciences

Capgemini Engineering; Wallonië; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Hybrid work

Learning platforms access

Global leader in engineering services

Job summary

Capgemini Engineering is seeking a Computer System Validation (CSV) Engineer to ensure computerized systems 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 develop and execute validation protocols, implement ISPE GAMP5 principles, and analyze a wide range of technical systems in pharmaceutical environments.

Qualifications

• Minimum 5+ years experience in validation and qualification in the pharmaceutical industry or equivalent environments.
• Strong knowledge of ISPE GAMP5 principles applied to quality, operational and project contexts.
• Excellent analytical skills to contribute to validation strategies and CSV activities.
• Fluency in French and English (written and spoken).

Responsibilities

• 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 in regulated environments.

Skills

CSV validation

GAMP5 knowledge

Analytical skills

French & English

Job description

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

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

Your profile

• Minimum 5+ 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)

What you will love about working here

• 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.