Industrialization Biology Engineer Transfer(H/F)

**Stilla is hiring an Industrialization and Validation Engineer**

Who we are

Stilla Technologies is a European Life Science company based in Paris whose aim is to empower scientists with pioneering digital PCR solutions to build the future of genetic testing.

Our multi-disciplinary team in microfluidics, mechanical engineering, biology, and software shares a passion for building successful Life Science Products based on deep technological innovation. We are pursuing a huge potential market on which we have the potential become the new leader.

**The principal missions of the Industrialization and Validation Engineer post are**:
In the Indus/QC team, she/he is in charge of the transfer and industrialization validation of new products and new processes of Stilla Technologies.

She/he is working with QC, R&D and Production teams in order to:
**Manage the Industrialization of new Stilla products**:

- Requirement definition for Industrialization part
- Selection of providers
- Oversee of development steps and/or external industrialization steps (Improvement of product, qualification IQC/FQC and implementation of new methods or material, prototypes or pilot lots validation, help in IQ/OQ/PQ process)
- Quality documentation for the product/process
- Scheduling and organization of required studies (stability, CEM, ISTA, ) with the aim of description of performances and regulatory folder completion
- Discussions around and implementation of Supply and quality agreements
- Technical survey for PCR technologies and associated process
- Support quality audits

**Be the technical reference to ensure the continuous improvement**:

- After customer complaint, Unconformity or other internal event, Management of continuous improvement of Stilla products
- Troubleshooting of technical and/or process issues
- Technical contact for the suppliers to solve the quality issues

**Promote the results by**:

- Data presentation (reports, PPT presentations, Instructions,)
- Data registration for grantable results and ideas

**Manage a project team and transversal teams**:

- Project coordination during industrialization steps, with the management of all teams, including R&D, Ops, Marketing/Sales, Quality and external teams
- Carrying out technical operations
- Efficient relationship between teams
- Project management according to all procedures in force (QMS, V cycle, Agile method,)

**Profile**
- Master 2, Industrialization Engineer with a good understanding of PCR technology, Biomolecular PhD, Biomedical PhD or Biochemical PhD
- With at least 2 years of experience in development or industrialization of IVD tests or biomedical machines
- Good technical expertise in Molecular Biology, ideally dPCR or qPCR and/or medical automates and fluorescence imagery
- Expertise in data analysis, in scheduling tools and Microsoft suite for reports, presentations,
- Good knowledge of quality and regulatory standards in DM-DIV (ISO 13485, IVDD/IVDR, ISO23640,)
- French and English fluently
- Ability to manage teams and to negotiate with subcontractors, support quality audits

Autonomous, organized and proactive, the she/he loves a challenge and shows intellectual curiosity with a strong team spirit and initiatives.

**Why join us?**
- Build amazing tools for the Life Sciences & Diagnostics in a challenging environment
- Join a young and dynamic Life Science company growing at a 3-digit pace
- Work with a team who shares a passion for building successful Life Science Products based on deep technological innovations.
- Bring significant contributions to concrete products.

Type d'emploi : Temps plein, CDI

Avantages:

- Participation au Transport
- Titre-restaurant

Programmation:

- Du Lundi au Vendredi
- Repos le week-end
- Travail en journée