Industrialization and Engineer Transfer (H/F)
VILLEJUIF, 94
il y a 9 jours
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. It operates within a cross‑functional, 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, regulatory, and logistics requirements, and evaluate and select suppliers or subcontractors according to quality, cost, time, and 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) to 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.)
- 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
Qualifications and Experience
- Strong engineering background: Master’s or Engineer degree with 5‑8 years minimum in electrical or 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 optimise product performance
- Solid experience in control design and definition; good knowledge of CQA, AQL, residual risk (customer/supplier), control method capability (Cmc), and process capability (Cp/Cpk)
- Regulated environment expertise: comfortable working in ISO 13485, GMP‑like systems
- Project management experience: leader, autonomous, organised, proactive in project management
- External communication: ability to negotiate with teams, suppliers or subcontractors and support quality audits
- Team spirit: clear communication, intellectual curiosity and sharing spirit
- Languages: fluent in French; high‑level English for regular professional use
Compensation and Benefits
45‑55k EUR (based on experience)
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Entreprise
Stilla Technologies Inc
Plateforme de publication
WHATJOBS
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