We are hiring an Industrialization and Validation Engineer!
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 IQ/OQ/PQ and implementation of new methods or material, prototypes or pilot lots validation)
• 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, …)

• Master 2, Industrialization Engineer, 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 Focused Genomics in a challenging environment
• Join a young and dynamic Life Science company
• Work with a team who shares a passion for building successful Life Science Products based on deep technological innovations.

Location: Villejuif (94 800)