Chargement en cours

Industrialization and Engineer Transfer

VILLEJUIF, 94
il y a 4 jours

Présentation

Job description

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, maintainances) 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 (supply agreement, quality agreement).

Key Skills & Profile

  • - Master’s degree / Engineer degree with solid experience in electrical, mechanical engineering within biotech, medtech, diagnostics, or microfluidics systems.
  • 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.

Position located in Villejuif. Immediate start.

Manager: Industrialization Director

Remote work: Yes, occasionally

Compensation and Benefits

  • 45-55k€ Based on experience
  • Mutuelle Alan

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
#J-18808-Ljbffr
Entreprise
UNAVAILABLE
Plateforme de publication
WHATJOBS
Offres pouvant vous intéresser
Soyez le premier à postuler aux nouvelles offres
Soyez le premier à postuler aux nouvelles offres
Créez gratuitement et simplement une alerte pour être averti de l’ajout de nouvelles offres correspondant à vos attentes.
* Champs obligatoires
Ex: boulanger, comptable ou infirmière
Alerte crée avec succès