Engineer Ii, Support Production

il y a 2 semaines


Paris, France Cellectis Temps plein

Prise de poste non définie CAP/ BEP/ TOTPI Paris

Nombre de poste : 1 CDI Rémunération non définie

**Description du poste et des missions**:
**À propos de Cellectis:
Cellectis est une entreprise d’édition du génome, qui développe les premiers produits thérapeutiques d’immunothérapies allogéniques fondées sur des cellules CAR-T, inventant le concept de cellules CAR-T ingéniérées sur étagère et prêtes à l’emploi pour le traitement de patients atteints de cancer, et une plateforme permettant de réaliser des modifications génétiques thérapeutiques dans les cellules souches hématopoïétiques dans diverses maladies.

Cellectis promeut l'égalité des chances, qui valorise la diversité et l’inclusion au sein de ses équipes. Notre politique de recrutement repose uniquement sur les qualifications inhérentes au poste à pourvoir et l’adhésion à nos valeurs **EDIT2** **:E**quité **D**étermination **I**ngéniosité **T**ravail en Equipe **T**ransparence & confiance.

Rejoignez une équipe engagée et passionnée de plus de 140 collaborateurs à Paris

**Descriptif du poste**:
**Missions principales**:

- Soutien et Amélioration continue des processus Production et Supply actuels pour:

- La montée en charge de l’usine pour soutenir les études cliniques de Cellectis
- La préparation du dossier d’enregistrement auprès des agences règlementaires
- Support Qualification : Participation active à la conception de nouvelles activités, notamment le démarrage de nouveaux produits (analyses de risques, activités de qualification, rédaction documentaire) en soutien du département Qualification.
- Support Production (en soutien du département Support Production):

- Participation active au processus des déviations : formalisation, investigation, évaluation de l’impact, CAPA, formation et coaching des Techniciens.
- Participation à la Revue (Production) des Dossiers de lots.
- Participation active aux lots de transferts, lots de lancement, et de validation
- Leader sur un ou plusieurs projets d’envergure (ex : démarrage d’atelier, optimisation de procédés, changement d’équipement ou de logiciel) et rédaction d’une partie de la documentation associée (URS, qualification de performance).
- Interactions avec les autres services (QC, QA, R&D) pour le partage d’information et la coordination d’activités interdépendantes.

**Profil souhaité**:
**Formation et expérience professionnelle requises**:

- De formation Ingénieur, Pharmacien, ou BAC+5
- Expérience professionnelle requise (> 10 ans) dans le domaine pharmaceutique (activité GMP) & expérience terrain
- Expérience opérationnelle dans la mise en place et l’amélioration d’activités, la gestion des déviations, Change control, CAPA
- Autonomie, rigueur et proactivité
- Efficacité
- Communication claire et précise
- Sens du travail en équipe
- Organisation du travail
- Bonne expression écrite et orale en français et bon niveau d’anglais
- Maitrise du pack Microsoft Office (Excel, Powerpoint, Word...)

**Vos avantages en rejoignant Cellectis**:

- Des projets innovants et un environnement de travail collaboratif
- Une rémunération motivante basée sur des objectifs annuels « SMART »
- Une couverture sociale sur mesure pour vous et vos proches
- Un restaurant d’entreprise sur place
- Un cadre de travail moderne et agréable avec espace détente, salle de sport, terrasses, potager et table de baby-foot
- Un CSE très actif proposant de nombreux avantages aux collaborateurs (médiathèque interne, massages assis, subventions culture et sport ) et une commission verte proposant des améliorations en faveur de l’environnement
- Des événements internes réguliers


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