Industrialization and Engineer Transfer (H/F)
Overview
Stilla Technologies is a Paris-based European biotechnology company that focuses on accelerating the development of next-generation genetic tests by providing biologists with tools for high-resolution genetic analysis. Stilla Technologies was founded in 2013 and is now part of Bio-Rad Laboratories as LSG-Paris entity. Since 2016, Stilla Technologies/Bio-Rad LSG-Paris provides research organizations specialized in molecular biology and genetic analysis. LSG-Paris has developed a range of digital PCR instruments (Naica®, Nio® and QX700™ systems), which, with microfluidic chips, dedicated reagents, and advanced data analysis software, enable analysis of many genetic biomarkers (multiplexing) with high sensitivity and precision. This technology supports new precision genetic tests in applications such as liquid biopsy, pre-natal testing, Gene Therapy, infectious disease, and GMO detection. Our multi-disciplinary teams in microfluidics, mechanical engineering, biology, and software build Life Science Products based on deep technological innovation. We aim to empower scientists with pioneering digital PCR solutions to advance genetic testing.
Position
We are currently looking for an Industrialization and Transfer 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. The role operates within a cross-functional and multi-disciplinary environment, requiring a comprehensive understanding of the entire system (machines, reagents, consumables).
Key Missions
- Definition of industrial specifications and project framework
- Establish a specifications document based on technical (R&D), marketing, quality and regulatory, and logistics requirements; evaluate and select suppliers or subcontractors according to Quality / Cost / Time / Reliability criteria
- Establish the schedule and budget for the prototype-to-industrial-product transfer phase
- Coordinate transfer phases
- Plan the production of industrial batches, define sampling and control criteria (incoming, in-process, final, maintenance); ensure products meet industry standards and customer needs
- Evaluate batch compliance and industrial performance (reproducibility, repeatability, etc.) and implement stability and 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 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 changes and/or transfer steps in the quality process using a quality tracking software
- Participate in the development and implementation of supply and quality processes
Qualifications
- Strong engineering background — Master’s degree / Engineer degree with solid experience (5-8 years minimum) in electrical, mechanical engineering within biotech, medtech, diagnostics, or microfluidics systems. Ideally, experience in transfer activities.
- Advanced analytical expertise — Solid experience with analyzing data and identifying trends to optimize product performance.
- Solid experience in Control design and definition — 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, proactive in project management.
- External communication — Ability to negotiate with several teams, suppliers or subcontractors and support quality audits.
- Team spirit — Easy and clear communication, intellectual curiosity with sharing spirit.
- Languages — Fluent in French; high-level English suitable for regular professional use.
Compensation and Benefits
45-55kEUR Based on experience.
Recruitment process
- HR video interview
- Interview with the direct Manager
- Interview with the team
- Comprehensive interview with the HR Director
- Interview with the N+2