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

1. Definition of industrial specifications & project framework

1. 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
2. Establish the schedule & budget for the prototype-to-industrial-product transfer phase

1. Coordinate transfer phases

1. Plan the production of industrial batches, define sampling & control criteria (incoming, in-process, final, maintenances) ensure that products meet industry standards and customer needs
2. Evaluate batch compliance & industrial performance (reproducibility, repeatability, etc.) and implement stability & transport studies
3. Qualify and validate production and/or subcontracting processes and ensure training for employees involved in the transfer (production staff, quality control, subcontractors, etc.)

1. Monitoring, Continuous Improvement and Optimization:

1. Analyze manufacturing and QC processes and product performance to identify areas for improvement and implement optimization strategies
2. Participate in the resolution process, working closely with cross-functional teams to address and mitigate potential problems
3. Drive continuous improvement initiatives, focusing on enhancing product performance and extending product lifecycles

1. Ensure the traceability of the project and product documentation

1. Establish quality documentation (instructions, forms, supporting documents, etc.) related to the product/process/changes
2. Record the traceability of the changes and/or transfer steps in the quality process using a quality tracking software
3. 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.

1. Advanced analytical expertise
   Solid expertise and experience with analyzing data and identifying trends to optimize product performance.
2. 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).
3. Regulated environment expertise
   Comfortable working in regulated environments (ISO 13485, GMP-like systems).
4. Project management experience
   Leader, autonomous, organized, taking challenges and being proactive in project management.
5. External communication
   Ability to negotiate with several teams, suppliers or subcontractors and to support quality audits.
6. Team spirit
   Easy and clear communication, intellectual curiosity with sharing spirit.

Language:

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

Position located in Villejuif. Immediate start.

Manager: Industrialization Director

Remote work: Yes, occasionally

Compensation and Benefits

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

Recruitment process:

1. HR video interview
2. Meeting with the direct Manager
3. Meeting with the team
4. Comprehensive interview with the HR Director
5. Interview with the N+2

Legal Entity: (FRA_2076)Stilla Technologies

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