Process Validation Engineer
vor 3 Wochen
Agap2 est un groupe européen d’ingénierie et de conseil opérationnel fondé en 2005 et spécialisé dans l’industrie. Nous travaillons dans les secteurs de la pharmacie, de la biotechnologie, des dispositifs médicaux, de l’horlogerie et de la mécanique de précision.
En tant que consultant, vous serez amené à accompagner nos clients dans la réalisation de leurs projets sur site en apportant votre expertise et vos compétences. Vous êtes agile et désireux de vous adapter à différents environnements de travail qui alimenteront votre curiosité de voir ce qui se cache derrière les portes fermées des plus grands projets du portefeuille de nos clients.
Vos missionsL'ingénieur en Validation sera en charge de supporter nos clients, des sites de production pharmaceutiques dans leurs activités de CPV (Continuous Process Validation) :
- Assurer le suivi, la coordination et le traitement des données provenant de la CPV (Continuous Process Verification).
- Mener des investigations en cas d'OOT ou de non-conformité concernant un paramètre CQA.
- Évaluer les impacts du procédé lors de changements.
- Rédiger et suivre les protocoles de tests ou de validation du procédé de fabrication.
- Gérer les données du procédé pour le processus de fabrication.
- Apporter un soutien aux activités opérationnelles quotidiennes du département.
- Master ou diplôme d'ingénieur en biotechnologie, chimie ou un autre domaine
- Excellente maîtrise des procédés pharmaceutiques, de préférence de la production de drug substance biotechnologique
- Connaissance approfondie des activités de validation des procédés (analyse des risques, plan de validation, protocoles de validation, Continuous Process Verification).
- Familiarité avec les exigences réglementaires pharmaceutiques BPF (Bonnes Pratiques de Fabrication).
- Maîtrise du francis et de l'anglais.
- Nationalité suisse ou de l'UE, ou permis de travail suisse valide
Nous vous remercions pour votre intérêt pour cette opportunité, notez que seuls les candidats sélectionnés pour un premier échange seront contactés.
Engineering Consulting in the fields of Life Science, Automation, Energy, Railway, Construction with Offices in Zürich, Basel und Lausanne
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