CSV Engineer | Life Science

Capgemini Engineering; Diegem; Sur place; EUR 50 000 - 61 000; Plein temps

Résumé du poste

Capgemini Engineering in Belgium seeks a Computer System Validation (CSV) Engineer to ensure computerized systems in regulated environments comply with standards and perform as intended. You will collaborate with cross-functional teams to develop and execute validation strategies aligned with industry regulations.

The role emphasizes developing and executing validation protocols in pharmaceutical environments, applying ISPE GAMP5 principles across quality, operations and projects, and validating

Qualifications

• 3+ years of validation and qualification experience in the pharmaceutical industry (FDA, Eudralex, WHO) or equivalent environments (food, cosmetics).
• Strong knowledge of ISPE GAMP5 principles and their application to quality, operations and projects.
• Excellent analytical skills to contribute to validation strategies and CSV activities.

Responsabilités

• 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.

Connaissances

Validation & qualification experience

ISPE GAMP5 knowledge

Analytical skills

Bilingual French & English

Description du poste

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 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)

What You'll Love About Working Here

• Career acceleration programs - From associate to leaders and beyond, get support in your career at every stage with award-winning programs such as our leadership development program, Connected Manager, to accelerate your growth and develop your expertise.
• Continuous feedback - We take a human-centric approach to foster growth and performance. Our performance management tool GetSuccess enables continuous feedback, quarterly check-ins with managers, and ongoing performance discussions.
• FlexAbroad - Employees in 20+ countries can work abroad for up to 45 days in a 12-month period.

For this role, the gross annual starting base salary is 55.000 euro (full-time). This covers base pay only; any bonuses, incentives, and benefits will be discussed later in the recruitment process. Candidates with additional experience or qualifications may receive a higher offer, determined by objective, gender-neutral criteria and consistent with our pay principles. If a collective labour agreement applies, we will explain the relevant pay terms at the interview stage. Note: We never ask for your current or previous salary during our hiring process.