CSV Engineer | Life Science
Il y a 4 semaines
Machelen, Flanders, Belgique
Capgemini
Temps plein
55 000 € Contrat
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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'll 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. 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.
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'll 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. 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.