Ingénieur validation CSV
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Job description
Context
We seek an experienced Validation Engineer specializing in Computer System Validation (CSV) for GxP-regulated pharmaceutical environments.
You will validate computerized systems throughout their lifecycle—from system categorization and user requirements to system impact analysis and validation testing (IQ, OQ, PQ)—ensuring compliance with Sanofi standards and regulatory requirements.
Missions
- Author and maintain comprehensive validation documentation
- Execute CSV activities for DCS and PLC automated systems, including interfaces (Design Qualifications, System Impact Analysis, IQ/OQ/PQ Protocols, Testing, Reports)
- Ensure GxP regulatory compliance across all validated systems
- Support change control processes and deviation management
Tools & Environment
- Automated systems such as Emerson DeltaV, Siemens PLC/HMI (preferred)
- Validation documentation and protocols (IQ, OQ, PQ)
- Regulatory frameworks: 21 CFR Part 11, EU Annex 11, GAMP 5
- Platforms: Kneat (preferred)
- IT infrastructure qualification (plus)
Working Conditions
- Validation role within a GxP-regulated pharmaceutical environment
- Collaboration with System Owners, Engineering, and CQV teams
- Focus on audit-ready deliverables and regulatory compliance
- Emphasis on risk-based validation approach and multidisciplinary project coordination
Requirements
- 2-3 years validation experience with CSV exposure
- Strong knowledge of change control and deviation management
- Expertise in GMP guidelines and Data Integrity principles
- Regulatory compliance knowledge: 21 CFR Part 11, EU Annex 11, GAMP 5
- Hands-on automated systems validation experience
- Experience with process automation systems (Emerson DeltaV, Siemens PLC/HMI) (preferred)
- Design Qualification execution experience (preferred)
- Familiarity with risk-based validation approach (preferred)
- Knowledge of upstream/downstream bioprocessing (preferred)
- Experience in Sanofi environment (preferred)
- Experience with Kneat platform (preferred)
- IT infrastructure Qualification (plus)
- Analytical mindset with systematic problem-solving abilities
- Structured approach to multidisciplinary project coordination
- Strong documentation skills for audit-ready deliverables
- Proactive compliance awareness with risk identification capabilities
- Excellent communication for cross-functional collaboration with System Owners, Engineering, and CQV teams
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