Sanofi is looking to ensure that all automation computerized systems used in manufacturing processes are validated in compliance with Sanofi’s quality requirements and the applicable cGMP regulations.
Requirements
- Knowledge in DCS, PLC, SCADA, BMS, EMS and HMI systems
- Understanding of ISA-95, ISA-88 standards.
- Solid technical knowledge in the use and application of risk- and science-based approaches to CSV.
- Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems.
- Familiar with Digital 4.0 concepts and control systems.
- Experience with ensuring Data Integrity in computerized systems.
- Expertise in OT system validation processes and lifecycle.
Responsibilities
- The Computer System Validation Engineer will be responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi’s quality requirements and fulfil regulatory expectations.
- Design and execute validation protocols and testing.
- Create and manage validation documentation.
- Troubleshoot validation issues, conduct risk assessments and support audit.
- Record and analyze deviations and downtime for root cause identification.
- Provide technical expertise in CS validation lifecycle for OT systems.
- Ensure OT systems comply with regulatory and industry standards.
Other
- Bachelor’s or Master’s degree in Science, Engineering, or related Life Sciences or Technology fields.
- 4+ years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
- Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.
- Good communication skills to present validation strategies to the site management and other functions.
- Able to work independently with little supervision.
