Production Specialist USP

2 weeks ago


Madison, United States CareerBuilder Full time

En tant que Production Specialist, vous tes responsable de la coordination de lexcution des procds de production de matriel de grade clinique ou commercial, selon les requis documentaires (SOP, WI, MBR), les normes EHS, les rgles cGMP et dans le respect de la mthode de production.
Vous jouez un rle de coordinateur des activits de lquipe : rpartition des tches entre les membres de lquipe et organisation du travail pour atteindre les objectifs projets.
Vous assurez un rle de reprsentant de la production dans les meetings projets (deputy production manager).
Vous tes le relais des bonnes pratiques et de la formation des principes scientifiques et de pratique sur le terrain dans le domaine USP : production de banques cellulaires et virales, amplification cellulaire (en suspension ou en adhrence), culture en bioracteur (en suspension ou en adhrence), production virale, rcolte et clarification
Grce vos connaissances techniques et scientifiques, vous suivez les projets du dbut limplmentation sur le terrain (coordination des projets, rdaction de protocoles, batch record et documents associs, accompagnement et training des quipes sur le terrain).
Participation la gestion qualit : revue batch record, amlioration continue, investigations.
Vous grez le planning oprationnel court terme et vous tes le backup oprationnel du manager de production.
Vous tes en charge de linvestigation de dviation et vous participez la dfinition et la mise en place de CAPA
Vous tes responsable de la gestion des quipements ncessaires un projet et vous tes responsable du suivi du cycle de vie de familles dquipements de votre discipline en collaboration avec lquipe de maintenance.
Vous particip activement aux transferts des nouveaux produits en collaboration avec les ingnieurs MSAT et tes le relais de la production dans les runions projets et techniques.
Dans la gestion du matriel vous vrifiez et transfrez vers la zone de production les matriels impliqus dans les productions cGMP et vous grez la propret et de la scurit dans votre environnement de travail
Vous participez la rdaction et la rvision des MBR/SOP/WI/FRM et vous grez la rdaction et le suivi de certains protocoles
Bachelier ou Master dans une disciplie des sciences de la vie
Au moins ans 8 ans dexprience industrielle en environnement de production GMP (USP) de prfrence dans le domaine de la thrapie cellulaire ou des vecteurs viraux.
Vous tes autonome avec un bon esprit dquipe. Vous avez la capacit proposer des solutions techniques aux problmes rencontrs et faire la synthse de diffrents avis (inputs).
Agilit: capacit travailler sur plusieurs projets dans un environnement matriciel et multi-tches
Esprit curieux, dsireux de dvelopper ses connaissances et orient amlioration continue
Organis et orient rsultats.
Capacit agir comme mentor et rfrent technique dans sa discipline pour les nouveaux et collaborateurs plus juniors.
Franais comme langue native et bonne comprhension de langlais (coute et crit) capacit communiquer en anglais.

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