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Cdi - Manufacturing Process Automation Compliance

Il y a 5 mois


IllkirchGraffenstaden, France Lilly Temps plein

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**_ Missions :_**

Dans une équipe assurant à la fois les travaux neufs et le support à la production, vous êtes le contact Qualité & Méthodes Process Automation privilégié local et avec les fonctions globales. Vous aurez en charge la responsabilité de:

- Piloter le programme Data Integrity du périmètre process automation
- Décliner localement les procédures globales qualité (LQP & GQS) relatives à la sécurité informatique, cybersécurité, Data Integrity et à la validation des systèmes automatisés et robotisés,
- Réaliser les analyses de GAP lors des révisions des LQP et des GQS,
- Définir les stratégies et les méthodes applicables au process automation (ex : spécifications d’architecture, sauvegardes, etc ),
- Définir les méthodes de gestion du parc d'automate, de device et de postes de supervision (Ex: FT Asset manager),
- Définir la sécurité informatique des systèmes automatisés du site,
- De participer et répondre aux audits internes et réglementaires,
- Être le représentant local dans les meetings et groupes de travail globaux et faire valoir les besoins du site dans l'évolutions des standards globaux

**_ Profil_**:
Titulaire d’un **diplôme d’Ingénieur** vous avez une bonne connaissance générale des **systèmes informatiques** ou **d'automatisme**. Vous avez idéalement une formation ou une expérience professionnelle **de qualiticien** dans le domaine des automates industriels et des systèmes de supervision, et savez mettre en œuvre des processus efficients dans la **rigueur **et le respect d'un **contexte réglementaire** exigeant. Vous parlez couramment l’**anglais**. Pour remplir cette fonction transversale riche, dans un environnement motivant, vous êtes **fédérateur**, **force de proposition** et de **conviction**, et doté de réelles **qualités relationnelles**. Vous savez travailler en **autonomie** ou en **équipe** et disposez d’un **sens aigu d’analyse** et de **synthèse**.

**_ Le petit « plus » :_**
- Vous avez une expérience dans les systèmes automatisés de l’industrie pharmaceutique et vous connaissez les GMP/BPF.

*** **_Les conditions _**_:_
- Poste en CDI - statut Cadre
- Cycle de travail : journée avec périodes d’astreintes
- Avantages sociaux : intéressement/participation, mutuelle santé & prévoyance, formule de retraite sur complémentaire, prime transport, salles de fitness et musique, restaurants, conciergerie etc.
- Parcours de formation terrain et d’intégration assuré
- Plan de carrière : évolutions à 3 ans
- Cadre de travail appréciable : société qui investit aussi bien dans les équipements que dans l’humain. Ainsi, vous pourrez participer à des projets stimulants dans un environnement en forte évolution
- Poste basé à Fegersheim (15 min du centre de Strasbourg, usine desservie en transports en commun et par des pistes cyclables)

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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