Votre mission :
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. 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 and project framework
Establish a specifications document based on all technical (R and D), marketing, quality and regulatory, and logistics requirements and 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, maintenances) ensure that 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 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.
Votre profil :
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:
1- HR video interview
2- Interview with the direct Manager
3- Interview with the team
4- Comprehensive interview with the HR Director
5- Interview with the N+2.
A propos de Stilla Technologies :
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 is providing research organizations specialized in molecular biology and genetic analysis. LSG-Paris has developed a range of digital PCR instruments (Naica®, Nio® and now QX700™ systems), which, combined with microfluidic chips, dedicated reagents, and advanced data analysis software, allow the analysis of an unrivalled number of genetic biomarkers (multiplexing) with very high sensitivity and precision. This cutting-edge technology paves the way for new precision genetic tests in a wide range of applications such as liquid biopsy tests for cancer diagnostics, pre-natal testing, Gene Therapy, infectious disease or GMO detection.
Our multi-disciplinary teams in microfluidics, mechanical engineering, biology, and software shares a passion for building successful Life Science Products based on deep technological innovation. We aim to empower scientists with pioneering digital PCR solutions to build the future of genetic testing.
