Industrialization and Engineer Transfer
VILLEJUIF, 94
il y a 4 jours
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 a 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, maintenances) to 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
Entreprise
Bio-Rad Laboratories, Inc
Plateforme de publication
WHATJOBS
Offres pouvant vous intéresser
VILLEJUIF, 94
il y a 4 jours
VILLEJUIF, 94
il y a 1 jour
VILLEJUIF, 94
il y a 1 jour
LA ROCHELLE
il y a 27 jours