Single Use Systems Engineer | Life Science
CapgeminiAbout the role
Capgemini Engineering, leader mondial des services d'ingénierie , rassemble des équipes d'ingénieurs , de scientifiques et d'architectes pour aider les entreprises les plus innovantes dans le monde à libérer leur potentiel . Des voitures autonomes aux robots qui sauvent des vies, nos experts en technologies digitales et logicielles sortent des sentiers battus en fournissant des services uniques de R&D et d'ingénierie dans tous les secteurs d'activité . Rejoignez nous pour une carrière pleine d'opportunités , où vous pouvez faire la différence et où aucun jour ne se ressemble
Your Role
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.
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 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.
Your Profile
- 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.
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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.
What You'll Love About Working Here
Inclusive leadership – Capgemini collaborates with global organizations to strengthen an equal opportunities framework, including promotion and pay, and to empower our leaders to develop inclusive behaviors and combat bias (97% of our VPs went through training on unconscious biases).
Tech for Societal Solutions – We're committed to addressing emerging crises, be it humanitarian, health, or biodiversity, to the best of our abilities. Collaborating with projects like ITER to build a safer, large-scale source of energy, our global scientists and experts work every day to make the world a better place.
Continuous feedback – We take a human-centric approach to foster growth and performance. Our performance management tool GetSuccess enables continuous feedback, quarterly check-ins with managers, and ongoing performance discussions.
Capgemini, partenaire de la transformation business et technologique de ses clients, les accompagne dans leur transition vers un monde plus digital et durable, tout en créant un impact p
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