Senior Engineer - Process Capability & Quality Strategy (H/F)
Société : Stilla Technologies Lieu : Val-de-Marne (Île-de-France)
Présentation de l'entreprise
Stilla Technologies is a Paris-based European biotechnology company that focuses on accelerating the development of next-generation genetic tests by providing biologists with tools for high-resolution genetic analysis.
Stilla Technologies was founded in 2013 and is now part of Bio-Rad Laboratories as LSG-Paris entity.
Since 2016, Stilla Technologies/Bio-Rad LSG-Paris is providing research organizations specialized in molecular biology and genetic analysis. LSG-Paris has developed a range of digital PCR instruments (Naica®, Nio® and now QX700™ systems), which, combined with microfluidic chips, dedicated reagents, and advanced data analysis software, allow the analysis of an unrivalled number of genetic biomarkers (multiplexing) with very high sensitivity and precision. This cutting-edge technology paves the way for new precision genetic tests in a wide range of applications such as liquid biopsy tests for cancer diagnostics, pre-natal testing, Gene Therapy, infectious disease or GMO detection.
Our multi-disciplinary teams in microfluidics, mechanical engineering, biology, and software shares a passion for building successful Life Science Products based on deep technological innovation. We aim to empower scientists with pioneering digital PCR solutions to build the future of genetic testing.
Descriptif du poste
Société : Stilla Technologies Catégorie : Offre emploi CDI Activité : Services aux entreprises Lieu : Val-de-Marne (Île-de-France) Salaire : 50000
Mission
We are currently looking for a Senior Engineer - Process Capability & Quality Strategy to join the Transfer and Industrialization team (TnOP) within the Manufacturing Operations department. The exciting primary responsibility of this role will be to facilitate the QC harmonization of all LSG-Paris products (machines and reagents), with potential expansion to the QC harmonization of LSG products more broadly. Thus, this position involves data analysis with understanding of the entire system (machines, reagents, consumables), as well as a transversal management of change proposals.
Key Missions
- Manufacturing & QC process improvement for instrument, microfluidic and reagent products
Perform critical reviews of existing manufacturing and QC processes, challenge the capability of the control method (cmc) and propose science-based and data-based process improvements.
- CQA & acceptance criteria redesign
Challenge Critical Quality Attributes and acceptance (CQA) thresholds using first-principles understanding, risk analysis, and empirical evidence.
- Historical data mining & synthesis
Analyze multi-year QC, manufacturing, deviations, and field performance data to establish statistically robust correlations between process parameters, CQAs, and real-world performance.
- Risk-based QC strategy
Implement a modern, risk-based QC framework: focus controls where they add value, remove over-control where risk is low.
- Process capability & variability reduction
In coordination with existing teams of Manufacturing, QC and Industrialization (internal and external), quantify process capability (Cp/Cpk), identify dominant sources of variation, and drive targeted improvements to increase robustness and yield.
-Change management & implementation
Work with the existing teams of Manufacturing, QC and Industrialization (internal and external) to lead the practical deployment of new processes and specifications into production, ensuring smooth transition, minimal disruption, and buy-in from manufacturing and QC teams.
-Documentation & compliance to the Company's QMS
- Cross-functional technical leadership
- Decision-grade reporting to management.
Profil recherché
Strong process engineering background
- Engineering degree or PhD (process engineering, bio/medtech, microfluidics, mechanical engineering, or equivalent)
- Solid experience (5-8 years minimum) in manufacturing process engineering within biotech, medtech, diagnostics, or microfluidics systems, with good knowledge of CQA, AQL, residual risk (customer/supplier)..
- Advanced statistical expertise, leveraging LLMs
Solid expertise and experience with the statistical tools required for the position, such as trend analysis and data-driven threshold setting; must have an experience in leveraging LLMs to strengthen and accelerate such statistical analysis.
- Scientific rigor & systems thinking
Ability to reason from physical/biological principles, not just historical specs; comfortable challenging "because we've always done it this way".
- Data-savvy and hands-on
Comfortable working directly with raw QC/manufacturing datasets; capable of using full capabilities of Excel, JMP, Python/R coupled with LLMs.
- Strong change leadership
Ability to influence experienced operators, QC analysts, and engineers; pragmatic, credible, and respectful of shop-floor reality; capable of managing a small team (intern, assistant engineer, engineer)
- Clear communicator
Able to explain statistical and technical concepts clearly to non-experts and senior management.
- Autonomous and structured
Capable of leading a multi-month, complex improvement program with minimal supervision.
- Quality system fluency
Comfortable working in regulated environments (ISO 13485, GMP-like systems).
- Fluent in French
- High-level English suitable for regular professional use.
Compensation and Benefits
50-60kEUR Based on experience.
Recruitment process:
HR video interview
Meeting with the direct Manager
Meeting with the team
Comprehensive interview with the HR Director
