Quality Control Engineer

Il y a 2 mois

Strasbourg, France Core Biogenesis Temps plein

Core Biogenesis is a rapidly scaling biotechnology startup, based in Paris and Strasbourg, France. Founded in 2020 by Chouaïb Meziadi and Alexandre Reeber, it is backed by some of the best European investors including XAnge and Blue Horizon Ventures.

We are looking for a motivated Quality Control Engineer to join our team and work alongside our QC Manager.

Your responsibility will be to develop and implement QC analytical tests to support new products and to conduct routine testing to ensure that established products meet specification,

You will also be tasked with identifying areas for quality control improvement, and implement those accordingly.

**Responsibilities**:

- Assist in development, feasibility testing and validation of new analytical methods
- Perform analytical tests on routine, stability and research samples (raw materials, in-process samples and finished products)
- Perform routine analysis and data reporting according to established specifications, test methods and Good Documentation Practices (GDocPs)
- Perform technical review of quality control data
- Perform equipment calibrations and qualifications
- Generate test protocols, reports and general procedures related to QC
- Perform laboratory-related investigations and assist in complaint investigations regarding product quality
- Optimize quality processes according to the company's feasibility constraints.
- Assist in development and implementation of Corrective and Preventive Actions (CAPAs) as needed

**Requirements**:

- Relevant academic degree (BA or MSc) in Engineering, Chemistry, Biology or Laboratory science preferred
- Previous quality control experience (+2-4 years minimum) in a regulated environment (such as chemical, food or pharmaceutical manufacturing)
- Experience with cell culture (maintaining cell lines and performing bioactivity/efficacy assays) required
- Knowledge of analytical techniques (HPLC/UPLC experience preferred)
- Experience in method development and/or validation preferred
- Strong verbal and written communication skills (EN/FR)

**Benefits**
- Competitive salary
- Remote work
- Equity

**Description**:
Core Biogenesis est une startup de biotechnologie en pleine expansion, basée à Paris et à Strasbourg, en France. Fondée en 2020 par Chouaïb Meziadi et Alexandre Reeber, elle est soutenue par certains des meilleurs investisseurs européens dont XAnge et Blue Horizon Ventures.

Nous recherchons un Ingénieur Contrôle Qualité motivé pour rejoindre notre équipe et travailler aux côtés de notre Responsable Contrôle Qualité.

Vous serez chargé(e) de développer et de mettre en œuvre des tests analytiques de contrôle de la qualité pour soutenir les nouveaux produits et de mener des tests de routine pour s'assurer que les produits établis répondent aux spécifications,

Vous serez également chargé(e) d'identifier les domaines d'amélioration du contrôle de la qualité et de les mettre en œuvre en conséquence.

**Responsabilités**:

- Participer au développement, aux essais de faisabilité et à la validation de nouvelles méthodes d'analyse
- Effectuer des tests analytiques sur des échantillons de routine, de stabilité et de recherche (matières premières, échantillons en cours de fabrication et produits finis)
- Effectuer des analyses de routine et établir des rapports de données conformément aux spécifications établies, aux méthodes d'essai et aux bonnes pratiques documentaires (GDocP)
- Procéder à l'examen technique des données de contrôle de la qualité
- Procéder à l'étalonnage et à la qualification des équipements
- Élaborer des protocoles d'essai, des rapports et des procédures générales liés au contrôle de la qualité
- Effectuer des enquêtes liées au laboratoire et participer aux enquêtes sur les plaintes concernant la qualité des produits
- Optimiser les processus de qualité en fonction des contraintes de faisabilité de l'entreprise
- Participer à l'élaboration et à la mise en œuvre d'actions correctives et préventives (CAPA), le cas échéant.

**Pré-requis**:

- Diplôme universitaire pertinent (BA ou MSc) en ingénierie, chimie, biologie ou sciences de laboratoire de préférence
- Expérience préalable du contrôle de la qualité (+2-4 ans minimum) dans un environnement réglementé (tel que la fabrication de produits chimiques, alimentaires ou pharmaceutiques)
- Expérience de la culture cellulaire (maintien de lignées cellulaires et réalisation d'essais de bio activité/efficacité) requise
- Connaissance des techniques analytiques (expérience HPLC/UPLC de préférence)
- Expérience en matière de développement et/ou de validation de méthodes, de préférence
- Solides compétences en communication orale et écrite (EN/FR)

**Informations Complémentaires**:

- Salaire compétitif
- Télétravail
- BSPCE

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