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About the role
As part of the MPU Validation Platform supporting vaccine manufacturing operations, the consultant will develop, maintain, and optimize a comprehensive database covering all Single Use Systems (SUS) used across manufacturing processes. The role supports traceability, compliance, standardization, and continuous improvement in a highly regulated pharmaceutical environment.
Key responsibilities
- Identify and map Single Use Systems (SUS) and components used across manufacturing units.
- Collect, verify, and consolidate technical documentation related to SUS assemblies and materials.
- Build and maintain a structured database containing component specifications, supplier information, bills of materials, certificates of compliance, and material and validation data.
- Ensure data integrity, accuracy, and consistency across all records.
- Collaborate with Validation, Quality Assurance, Manufacturing, Engineering, and Process teams to gather and validate information.
- Support change control, risk assessment, and regulatory compliance activities through accurate data management.
- Contribute to standardization initiatives across manufacturing sites and processes.
- Generate reports and dashboards to support operational and quality decision-making.
- Participate in continuous improvement projects related to SUS lifecycle management.
Your profile
- Bachelor's degree or higher in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, Industrial Operations, or a related field.
- Experience in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment.
- Strong data management and documentation skills.
- Ability to analyze technical information and maintain structured databases.
- Knowledge of GMP/GxP environments is highly desirable.
- Familiarity with validation processes, quality systems, or manufacturing operations is a plus.
- Excellent communication and stakeholder management skills.
- Ability to work with technical specifications and engineering documentation.
- Experience with ERP, MES, Quality Management Systems, or document management platforms is an advantage.
- Fluent French and professional working proficiency in English.
What you will deliver
- Comprehensive SUS inventory and database.
- Accurate and up-to-date technical documentation repository.
- Improved traceability of single-use components.
- Support for compliance, audit readiness, and validation activities.
- Standardized data management practices across manufacturing operations.
About Capgemini Engineering
Capgemini Engineering brings together engineers, scientists, and architects to help innovative companies unlock their potential through digital, software, research, and engineering services.