Validation Is Engineer

Sanofi UK

Le Trait, France
Base: €42,400.00 - €56,533; bonus/equity: not spec...
Validation of computerized systems
Quality documentation review
Regulatory compliance (fda, ema)
You will contribute to ensuring the compliance and reliability of computerized systems supporting the production of essential medicines

Job Summary

  • You will contribute to ensuring the compliance and reliability of computerized systems supporting the production of essential medicines.
  • Prepare and review qualification and validation documentation, ensuring compliance with regulatory requirements and company quality standards.
  • Shape the future of pharmaceutical manufacturing by contributing to strategic digital projects that concretely transform site operations.

Matching Summary

You will contribute to ensuring the compliance and reliability of computerized systems supporting the production of essential medicines.

Salary

Base: €42,400.00 - €56,533; Bonus/Equity: Not specified; Benefits: Employees may be eligible to participate in Company employee benefit programs.

Skills & Requirements

Must-have

  • Validation of computerized systems
  • Quality documentation review
  • Regulatory compliance (FDA, EMA)
  • Cross-functional team cooperation
  • Risk assessment and data analysis

Nice-to-have

  • Continuous improvement initiatives
  • External resource management
  • Scientific mindset and open-mindedness

Key Requirements

  • Experience in validation of computerized/automated systems in pharma/biotech
  • Knowledge of quality processes (change management, deviations, CAPA)
  • Experience in SI qualification/validation project management
  • Understanding of regulatory guidelines (FDA, EMA)
  • Ability to manage multiple validation projects
  • Scientific degree (Bac+5) or equivalent experience
  • English B2 level

Work Rights

Not specified

Tailored Resume

Cover Letter