Ingénieur·e Validation H/F

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Les missions du poste

Le Groupe FAREVA est aujourd'hui l'un des leaders mondiaux dans la sous-traitance de production et de conditionnement à façon de produits cosmétiques, pharmaceutiques, industriels et ménagers.

Le site de Production de FAREVA Mirabel est spécialisé dans la fabrication de médicaments stériles, ophtalmiques et injectables. Il est une filiale du groupe FAREVA et approvisionne ces médicaments dans le monde.

FAREVA Mirabel place au coeur de ses préoccupations, l'inclusion et la diversité en s'engageant notamment dans l'égalité professionnelle et l'emploi de salariés en situation de handicap.

Nous recrutons actuellement, dans le cadre d'un contrat à durée déterminé, un. e Ingénieur. e Validation pour notre site de Mirabel basé à Riom (63). Ce poste est rattaché à la Directrice Qualité.

Poste à pourvoir dès que possible pour une durée de 6 mois.

Activités Principales :

  1. Définir ou participer aux stratégies de validation
  2. Gérer les déviations liées à la validation des nettoyages et de la stérilisation des process (injectables et ophtalmiques), définir et mettre en place des CAPAs.
  3. Elaborer le plan de validation annuel.
  4. Rédiger et revoir les documents et les pré-requis de validation.
  5. Réaliser ou participer aux études de validation.
  6. Evaluer les non-conformités de calibration.
  7. Communiquer et prendre en compte les exigences clients.

Le profil recherché

Formation :
Vous êtes issu. e d'une formation Bac +5 Ingénieur avec une expérience de 5 ans en validation ou équivalent.

Compétences requises :

  1. Posséder des connaissances de la fabrication pharmaceutique en milieu stérile ainsi qu'une bonne connaissance des équipements de fabrication.
  2. Posséder des connaissances validation cleaning, stérilisation.
  3. Maîtriser les Bonnes Pratiques de Fabrication (BPF) et les réglementations pharmaceutiques (Annexe 15. ).
  4. Maîtriser les outils informatiques (Pack Office).
  5. Posséder une grande capacité d'adaptation et d'intégration.
  6. Savoir travailler en équipe particulièrement sur des sujets transverses.
  7. Posséder un esprit d'analyse et de synthèse.
  8. Être force de proposition et savoir communiquer efficacement.
  9. Posséder une culture du résultat.
  10. Maîtriser l'anglais.

Bienvenue chez Fareva Mirabel

Le Groupe FAREVA est aujourd'hui l'un des leaders mondiaux dans la sous-traitance de production et de conditionnement à façon de produits cosmétiques, pharmaceutiques, industriels et ménagers.

Le site de Production de FAREVA Mirabel est spécialisé dans la fabrication de médicaments stériles, ophtalmiques et injectables. Il est une filiale du groupe FAREVA et approvisionne ces médicaments dans le monde.

FAREVA Mirabel place au coeur de ses préoccupations, l'inclusion et la diversité en s'engageant notamment dans l'égalité professionnelle et l'emploi de salariés en situation de handicap.

Mais aussi.

Rémunération sur 13 mois
Participation aux frais kilométriques
Plan épargne entreprise avec abondement de l'employeur
RTT
Prime vacances
Restaurant d'entreprise


Read the full job description and apply online on the recuiter's web-site

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