Ingénieur validation des logiciels​/Ingénieure validation des logiciels

As part of the reinforcement of the IT & Validation teams of one of our partners, we are looking for a CSV Engineer able to lead the end-to-end validation activities of a large system in a regulated GxP environment.

The position is part of a complex industrial and pharmaceutical context involving manufacturing systems, infrastructure, automation, data integrity, and compliance requirements.

• Lead the end-to-end Computer System Validation activities of a complex system
• Drive validation strategy and execution
• Write and review CSV documentation including Validation Plans, Risk Assessments, Traceability Matrixes, IQ/OQ/PQ protocols and summary reports
• Ensure compliance with GxP, CSV and Data Integrity requirements throughout the project lifecycle
• Provide guidance and recommendations regarding validation approaches, compliance risks and remediation actions
• Coordinate validation activities with infrastructure, automation, manufacturing, quality and project teams
• Support deviation management, change controls and CAPA activities related to the validated environment
• Participate in audits and inspections preparation when required
• Ensure proper documentation, traceability and alignment with internal quality standards
• Act as a key contributor to the successful delivery of the validation project

• Strong experience in Computer System Validation within pharmaceutical or regulated environments
• Hands‑on experience with end‑to‑end validation of complex systems
• Experience validating large‑scale system is appreciated
• Ability to independently drive validation activities and interact with multiple stakeholders
• Good knowledge of GxP, CSV methodologies, Data Integrity and risk‑based validation approaches
• Experience writing and reviewing validation documentation autonomously
• Strong communication and coordination skills in international environments
• Ability to identify risks, challenge existing approaches and provide pragmatic recommendations
• Structured, rigorous and solution‑oriented mindset
• German is considered a huge advantage

• Master’s degree in Computer Science, Engineering, Life Sciences or equivalent
• Around 5 years or more of experience as CSV Engineer or Validation Lead in regulated environments
• Ability to work autonomously on complex validation projects
• Experience interacting with QA, IT, Automation and Manufacturing teams
• Strong analytical skills, autonomy and proactive mindset
• Fluent English required /
  German is a strong plus
• Experience in pharmaceutical or industrial environments is mandatory