Industrialization and Engineer Transfer

Job Description

We are currently looking for a Transfer and Sustaining Engineer to join the Transfer and Industrialization team (TnOP) within the Manufacturing Operations department. This role focuses on transferring and supporting external LSG-Paris products, especially the QX700™ machine and linked products. This role operates within a cross-functional and multi-disciplinary environment, requiring comprehensive understanding of the entire system (machines, reagents, consumables).

Key Missions

• Definition of industrial specifications & project framework
• Establish a specifications document based on all technical (R&D), marketing, quality & regulatory, and logistics requirements and evaluate and select suppliers or subcontractors according to Quality / Cost / Time / Reliability criteria
• Establish the schedule & budget for the prototype-to-industrial-product transfer phase
• Coordinate transfer phases
• Plan the production of industrial batches, define sampling & control criteria (incoming, in-process, final, maintenances) ensure that products meet industry standards and customer needs
• Evaluate batch compliance & industrial performance (reproducibility, repeatability, etc.) and implement stability & transport studies
• Qualify and validate production and/or subcontracting processes and ensure training for employees involved in the transfer (production staff, quality control, subcontractors, etc.)
• Monitoring, Continuous Improvement and Optimization:
• Analyze manufacturing and QC processes and product performance to identify areas for improvement and implement optimization strategies
• Participate in the resolution process, working closely with cross-functional teams to address and mitigate potential problems
• Drive continuous improvement initiatives, focusing on enhancing product performance and extending product lifecycles
• Ensure the traceability of the project and product documentation
• Establish quality documentation (instructions, forms, supporting documents, etc.) related to the product/process/changes
• Record the traceability of the changes and/or transfer steps in the quality process using a quality tracking software
• Participate in the development and implementation of supply and quality agreements (supply agreement, quality agreement)

Key Skills & Profile

• Master’s degree / Engineer degree with solid experience in electrical, mechanical engineering within biotech, medtech, diagnostics, or microfluidics systems.
• Advanced analytical expertise Solid expertise and experience with analyzing data and identifying trends to optimize product performance.
• Solid experience in Control design and definition Good knowledge in determination of CQA, AQL, residual risk (customer/supplier), control method capability (cmc), and process capability (Cp/Cpk).
• Regulated environment expertise Comfortable working in regulated environments (ISO 13485, GMP-like systems).
• Project management experience Leader, autonomous, organized, taking challenges and being proactive in project management.
• External communication Ability to negotiate with several teams, suppliers or subcontractors and to support quality audits.
• Team spirit Easy and clear communication, intellectual curiosity with sharing spirit.

Language

• Fluent in French
• High-level English suitable for regular professional use.

Position Details

Location: Villejuif. Immediate start.

Manager: Industrialization Director

Remote work: Yes, occasionally

Compensation And Benefits

• 45-55k€ Based on experience
• Mutuelle Alan

Recruitment Process

• HR video interview
• Meeting with the direct Manager
• Meeting with the team
• Comprehensive interview with the HR Director
• Interview with the N+2

Legal Entity: (FRA_2076)Stilla Technologies