Single Use Systems (SUS) Engineer _ Life Science
Role details
Job location
Tech stack
Job description
As part of the MPU Validation Platform supporting vaccine manufacturing operations, the consultant will be responsible for developing, maintaining, and optimizing a comprehensive database covering all Single Use Systems (SUS) utilized across manufacturing processes. This role will support traceability, compliance, standardization, and continuous improvement initiatives within a highly regulated pharmaceutical environment., * 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 and reliable database containing:
- Component specifications
- Supplier information
- Bills of Materials (BOM)
- Certificates of Compliance (CoC)
- 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.
Requirements
- Bachelor's degree or higher in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, Industrial Operations, or 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.
- 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.
- French: Fluent
- English: Professional working proficiency.
About the company
Capgemini ist einer der weltweit führenden Anbieter von Management- und IT-Beratung, Technologie-Services und Digitaler Transformation. Als ein Wegbereiter für Innovation unterstützt das Unternehmen seine Kunden bei deren komplexen Herausforderungen rund um Cloud, Digital und Plattformen.