CSV Engineer (Computer System Validation Engineer) - Casablanca

Company :

Capgemini Engineering is the brand of the Capgemini group that brings together the engineering and R&D services of Altran, a world leader in the sector which Capgemini finalized the acquisition of in 2020, and Capgemini's expertise in digital manufacturing. Thanks to in-depth sector knowledge and mastery of cutting-edge digital and software technologies, Capgemini Engineering supports the convergence of the physical and digital worlds. Combined with the Group's overall capabilities, it helps companies accelerate their transformation towards Intelligent Industry. Capgemini Engineering has more than 52,000 engineers and scientists in over 30 countries, in sectors such as aerospace, automotive, rail, communications, energy, life sciences, semiconductors, software and the Internet, space and defense, and consumer goods.

Capgemini Engineering is part of the Capgemini group, a global, responsible, and multicultural leader, bringing together 300,000 people in nearly 50 countries. A strategic partner for businesses in transforming their activities by leveraging the full power of technology, the Group is guided daily by its purpose: to unleash human energy through technology for an inclusive and sustainable future. With over 50 years of experience and extensive expertise in various business sectors, Capgemini is recognized by its clients for meeting all their needs, from strategy and design to operations management, by leveraging innovations in the constantly evolving fields of cloud, data, Artificial Intelligence, connectivity, software, digital engineering, and platforms. The Group generated revenue of 16 billion euros in 2020.

Get the Future You Want* - www.capgemini.com.

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.

Job :

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

Required profile :

 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

Head office address :

Desired personality traits :

Search for new things / novelty Need for objectivity Emotional distance Rationalism Need for autonomy Ambition