Engineer Specialist

Sanofi

The team is responsible for ensuring that all automated and computer-based systems used in regulated environments are compliant with industry standards and regulatory requirements, such as FDA 21 CFR Part 11, GAMP 5. This team plays a critical role in the lifecycle management of systems by overseeing validation planning, risk assessments, protocol development, testing, and documentation to ensure data integrity, system reliability, and consistent performance. By collaborating closely with IT, Quality Assurance, and system owners, the team helps to streamline operations, support digital transformation initiatives, and maintain a state of continual compliance in support of business and regulatory goals.

Main Responsibilities and Accountabilities:

• Develop and Implement CSV Strategy for OT Systems

Establish and execute a comprehensive Computerized System Validation (CSV) strategy tailored to Operational Technology (OT) systems such as PLCs, SCADA, and DCS. Utilize a risk-based, lifecycle-focused methodology aligned with industry best practices and regulatory expectations.

• Ensure Compliance with GMP, GAMP, and 21 CFR Part 11

Ensure all OT systems operate in full compliance with current Good Manufacturing Practices (cGMP), GAMP 5 guidelines, and FDA 21 CFR Part 11 requirements focusing on system validation, audit trails, electronic signatures, and data integrity.

• Manage the Full CSV Lifecycle for OT Systems

Oversee the entire validation lifecycle from User Requirements Specifications (URS) through system design, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ongoing maintenance, periodic review, and decommissioning.

• Lead CSV Activities Including Risk Assessments

Direct and conduct risk-based assessments to define validation scope, identify critical control points, and implement appropriate mitigation strategies. Provide subject matter expertise in validation planning and documentation.

• Implement Data Integrity Measures for OT Systems

Ensure robust data governance by embedding ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) into OT systems, with technical and procedural safeguards for secure and compliant data handling.

• Drive Continuous Improvement in CSV Practices

Promote a culture of continuous improvement by streamlining validation processes, leveraging digital tools, introducing standard templates, and fostering lean documentation practices while maintaining compliance.

• HSE Responsibilities:

Ensures HSE approval on any SOP that requires certain HSE precautions. Ensures HSE approval on any change.. Commitment to the appropriate PPE use. Follow the approved HSE policy and requirements. Following the statutory legislation concerning Health, Safety and environmental law. Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.

• Additional Accountabilities

Prepare for and participate in internal and external audits Respond to audit findings related to computerized systems Implement corrective and preventive actions as needed Work as part of validation teams with Business System Owners (BSOs), Technical System Owners (TSOs), and Subject Matter Experts (SMEs) Coordinate with user representatives, technical experts, and other quality representatives Communicate validation requirements to stakeholders

Education: Engineering or Science Bachelor's degree in a relevant field.

• Related Experience:

• From 1 to 3 years of experience.
• Understanding of GMP (Good Manufacturing Practice) regulations
• Knowledge of validation and qualification processes
• Familiarity with computerized systems validation

Soft skills:

• Good communication & Presentation skills and Reporting.
• Planning & organizing skills.
• Ability to co-ordinate several inter-departmental activities.
• Problem solving skills.
• Very good command of MS word, Excel & Power Point.