Single Use Systems Engineer | Life Science

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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.
• 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.