Job description

Company culture :

Capgemini Engineering is characterized by a strong collaborative culture, placing people, trust and teamwork at the core of its operations. A close management approach supports guidance, empowerment and talent development within a caring environment. This dynamic is reinforced by a significant innovation dimension, encouraging creativity, initiative and experimentation to deliver high-value solutions. It is also supported by a structured organizational foundation ensuring rigor and reliability, while a more moderate competitive component sustains a balanced performance mindset.

As a CSV Engineer, your main responsibilities will be:

• Ensure the validation of computerized systems (CSV) in compliance with pharmaceutical regulatory requirements (GxP, FDA, EMA)
• Apply the Validation Lifecycle according to the V-Model
• Implement a Risk-Based Approach
• Write and manage validation documentation:
  • Validation Plan
  • IQ / OQ / PQ Protocols
  • Validation Reports
• Analyze and formalize requirements:
  • URS (User Requirements Specifications)
  • FS (Functional Specifications)
  • DS (Design Specifications)
• Participate in the qualification of systems (equipment, software, automated systems)
• Collaborate with quality, IT, production, and automation teams

 CSV Engineer - Pharma Basic education level BAC +5 Specialization Industrial engineering, automation, industrial IT, or equivalent Junior to confirmed experience (1 to 5 years) Skills

• Good command of computerized system validation in a GxP environment
• Knowledge of standards: GAMP 5, 21 CFR Part 11
• Experience in IQ / OQ / PQ qualification
• Mastery of documentation: URS, FS, DS, validation plans, and reports
• Understanding of automated and computerized systems in the pharmaceutical industry
• Attention to detail, traceability, and regulatory compliance
• Analytical and risk management skills
• Good interpersonal skills and teamwork

Languages French: fluent English: professional