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Capgemini

Global consulting, technology services, outsourcing

Computer System Validation Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeCasablanca, MoroccoNo salary listed

About the Job

Requirements

  • A BAC+5 educational level in industrial engineering, automation, industrial computing, or equivalent is required.
  • The role is suitable for junior to confirmed candidates with 1 to 5 years of experience.
  • Strong knowledge of computerized system validation in a GxP environment is required.
  • Knowledge of GAMP 5 and 21 CFR Part 11 standards is required.
  • Experience with IQ, OQ, and PQ qualification is required.
  • Proficiency in validation documentation, including URS, FS, DS, validation plans, and validation reports, is required.
  • Understanding of automated and computerized systems in the pharmaceutical industry is required.
  • The candidate must demonstrate rigor, traceability, and regulatory compliance.
  • The candidate must be able to analyze and manage risks.
  • Professional fluency in French and English is required.

Responsibilities

  • Validate computerized systems in accordance with pharmaceutical regulatory requirements, including GxP, FDA, and EMA.
  • Apply the validation lifecycle according to the V-Model.
  • Implement a risk-based approach.
  • Draft and manage validation documentation, including validation plans, IQ/OQ/PQ protocols, and validation reports.
  • Analyze and formalize user requirements specifications (URS), functional specifications (FS), and design specifications (DS).
  • Participate in the qualification of equipment, software, and automated systems.
  • Collaborate with quality, IT, production, and automation teams.

About the Company

Capgemini

Global consulting, technology services, outsourcing

Capgemini provides consulting, technology services, and outsourcing to help organizations transform digitally. Its offerings include strategy and transformation consulting, system integration, application development, IT infrastructure management, and managed IT operations. It differentiates itself with a global presence in over 50 countries and a focus on applying AI, cloud, and cybersecurity to real business problems. Its goal is to help clients navigate digital transformation and improve efficiency and innovation through tailored, contract-based or managed services.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1967

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