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.

Strong engineering background
Master’s degree / Engineer degree with solid experience (5-8years minimum) in electrical, mechanical engineering within biotech, medtech, diagnostics, or microfluidics systems. Ideally, the candidate has an experience in Transfer activities.

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.

Compensation and Benefits

45-55kEUR Based on experience

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