On-site
toto -
Morocco , Boulemane
--
toto

Job Details

Job Description

Roles & Responsibilities

Capgemini Engineering, a global leader in engineering services, brings together teams of engineers, scientists, and architects to help the world's most innovative companies unlock their potential. From autonomous cars to life-saving robots, our digital and software technology experts go off the beaten path by providing unique R&D and engineering services across all sectors. Join us for a career full of opportunities, where you can make a difference and where no two days are alike.

About the position

As part of the development of our activities in the pharmaceutical sector, we are recruiting a CSV Engineer (Computer System Validation Engineer). You will work in a regulated environment (GxP) to ensure the compliance, reliability, and traceability of the IT systems used in production and quality processes.

Job responsibilities

As a CSV Engineer, your main responsibilities will be:

  • Ensure the validation of IT 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
  • Draft 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 system qualification (equipment, software, automated systems)
  • Collaborate with quality, IT, production, and automation teams

Some reasons to join us

Quality of life at work: Possibility of remote work in Morocco as well as internationally and autonomy in organizing your daily life, hybrid missions according to your preferences.

Continuous learning: access to dedicated training and certifications for your technology, personalized support, and a structured integration process.

Varied and high-impact projects: work with major companies in various sectors with stimulating business and technological challenges.

Our commitments and priorities:

The Capgemini Group promotes an inclusive culture in a multicultural and disability-friendly environment. By joining us, you will join a collective that values diversity, develops the potential of its talents, engages in solidarity initiatives with its partners, and is committed to reducing its environmental impact across all its sites and with its clients.

Capgemini is a global, responsible, and multicultural leader, bringing together nearly 300,000 people in over 50 countries. With 55 years of experience, we are a strategic partner for companies in the transformation of their activities by leveraging the full power of technology and innovation in constantly evolving fields such as cloud, data, Artificial Intelligence, connectivity, software, digital engineering, or platforms.

Desired Candidate Profile

Your profile for the position

  • Job title: CSV Engineer Pharma
  • Basic education level: BAC +5
  • Specialization: Industrial engineering, automation, industrial IT or equivalent
  • Experience: Junior confirmed (1-5 years)
  • Skills: Good command of IT system validation in 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 IT systems in the pharmaceutical industry, Sense of rigor, traceability, and regulatory compliance, Analytical and risk management skills, Good interpersonal skills and teamwork
  • Languages: French: fluent, English: professional

Similar Jobs

About toto
Morocco, Boulemane