Production Support Technician
Il y a 5 mois
Exothera is a contract development and manufacturing organization (CDMO) dedicated to virus and viral vector production. As a Univercells company, Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated process development/optimization to rapidly reach GMP clinical and commercial production of virus and viral vectors.
At Exothera and Univercells, our mission is to make health equally accessible to all.
We work every day on reinventing biomanufacturing processes and develop or integrate the next innovative technologies. With the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: Biologics available and affordable to all This job is the perfect opportunity to contribute to our mission and be impactful.
**MISSION**:
Pour notre entité de production consacrée aux vecteurs viraux basé à Jumet, nous sommes à la recherche de plusieurs
**technicien(ne)s support **dynamiques et passionnés dans les activités de production. Vous ferez partie intégrante des opérations de Production en assurant différentes activités transversales aux deux équipes Process USP & DSP et être ainsi le pilier du bon déroulement des opérations de la culture cellulaire à la purification. Au niveau opérationnel, vous rapportez au « Team Leader Production Support ».
L’équipe de Production Support assure l’approvisionnement des consommables, la préparation des milieux/tampons ainsi que d’autres activités de support (nettoyage du petit matériel, autoclaves,) à la production consacrée à de la fabrication multiproduits de substances biologiques actives ou produits issus de la biotechnologie, destinées à des essais cliniques ou à leur commercialisation.
**RESPONSIBILITIES**:
Vos responsabilités principales seront les suivantes:
- Assurer le transfert du matériel, échantillons et produit entre les différentes zones de production en respectant le planning de production et selon les procédures en vigueur
- Préparer tous les équipements et matériels nécessaires à la préparation des solutions (milieux/tampons) conformément aux normes EHS, cGMP, SOPs et aux exigences en matière de documentation de fabrication des lots cliniques ou pour la commercialisation
- Peser les matières premières
- Préparer les solutions (milieux et tampons) jusqu’à 500L
- Calculer les volumes, de masses et de concentrations de solutions
- Filtrer les milieux et les solutions tampons
- Exécuter les contrôles en cours de production tels que pH, conductivité, osmomètre,
- Contrôler l’intégrité des filtres
- Assembler les préparations et stériliser les équipements de production par autoclavage
- Supporter l’analyse aux évènements imprévus, investigations et le plan d’actions correctives et préventives (CAPA)
- Participer à la gestion de stock minimum nécessaire en matière / matériel pour assurer la production
- Assurer le nettoyage, la désinfection et le maintien en ordre des différentes zones de production
- Réaliser les monitoring environnement ; prélèvement, contrôle des paramètres de zone (pression, température,), relève les anomalies et les systèmes « Utilities » (air comprimé, gaz de process et eau purifié)
- Évacuer les déchets dans les zones de production et la décontamination par autoclavage si besoin
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