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Industrialization and Engineer Transfer (H/F)

VILLEJUIF, 94
il y a 18 heures

Industrialization and Engineer Transfer (H/F)

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\u2122 machine and linked products.

Key Missions

  • Define industrial specifications and project framework.
  • Establish specifications document combining R&D, marketing, quality, regulatory and logistics requirements; evaluate and select suppliers/subcontractors based on quality, cost, time, reliability.
  • Set schedule and budget for the prototype-to-industrial product transfer phase.
  • Coordinate transfer phases, plan production of industrial batches, define sampling and control criteria (incoming, in-process, final, maintenance) ensuring 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; provide training for employees involved in the transfer.
  • Analyze manufacturing and QC processes and product performance to identify improvement areas and implement optimization strategies.
  • Participate in resolution processes, 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 traceability of the project and product documentation, establishing quality documentation (instructions, forms, supporting documents, etc.).
  • Record traceability of changes/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 of experience in electrical, mechanical engineering within biotech, medtech, diagnostics, or microfluidics systems; preferably with transfer activities.
  • Advanced analytical expertise: solid experience in analyzing data, identifying trends to optimize product performance.
  • Control design and definition: knowledge of CQA, AQL, residual risk, control method capability (CMC), process capability (Cp/Cpk).
  • Regulated environment experience: comfortable working in ISO 13485, GMP-like systems.
  • Project management experience: leader, autonomous, organized, proactive.
  • External communication: ability to negotiate with teams, suppliers, subcontractors and support quality audits.
  • Team spirit: easy and clear communication, intellectual curiosity, sharing spirit.
  • Language: fluent in French; high-level English suitable for regular professional use.

Compensation and Benefits

45-55k EUR based on experience.

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Entreprise
Stilla-Technologies
Plateforme de publication
WHATJOBS
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