CU Engineering Profil & Kompetencer

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Profil & kompetencer
	Profil Jeppe Kjems er ejer af CU Engineering og specialist indenfor Critical Utilities til Farmaceutisk industri. Med uddannelse som Mejeriingeni਍.Sc.) og Engineering Technology Management samt 25 岳 international erfaring, heraf 17 岠indenfor farmaceutisk og bioteknologisk industri, har jeg erfaringer p?alle niveauer fra produktion til topledelse. Via min erfaring med forandrings ledelse fra forskelligartede organisationer, p?tv河 af kulturer og lande, er jeg i stand til at g堥n signifikant forskel i et projektforl͊eller et hektisk produktionsmilj? Mine personlige v沤ier er trov沤ighed, optimisme og livsenergi - og jeg l槧er stor v槴 p?at g堍 m嬠og dr�til virkelighed. Kernekompetencer Projektledelse Jeg har en bred erfaring med alle faser af projektledelse af farmaceutiske projekter fra id?koncept til gennemf嬳e og overdragelse. Desuden har jeg mere end 20 岳 engineering erfaring med sanit沴- og GMP kritisk design, tilsyn af projekter, deltaget i myndigheds- og leverand͊audits. Projekt planl槮ing fra den tidlige start fra id?over conceptual design & basic design, til validerings planer, detailed design, implementering og validering. Erfaring med projekt budgetansvar p?over DKK 100 millioner. Subject Matter Expert Subject Matter Expert j涮fԒisk Based Validation? Mange 岳 international erfaring med Critical Utilities p?alle niveauer fra fabriksgulvet til topledelse. Peer Review⬠Clean Utility specialist hos Novo Nordisk A/S, samt international og national CU foredragsholder (International Society of Pharmaceutical Engineering ISPE, Farmaceutiske Vandsystemer DK, R-3 og DTU). Procesoptimering Som f祠af Novo Nordisk fokus p? milj?og b沥dygtig produktion, har der vist sig mange signifikante besparelses muligheder med vand og energi - de fleste med attraktive tilbagebetalingstider. Mikrobiologisk uddannelse Min mikrobiologiske baggrund kombineret med teknisk erfaring har ofte vist sig af afg室e betydning i forbindelse med trouble shooting ved 崠Of Specifications?og udf嬳e af ᩬure Investigations? ضrige kompetencer Clean Utility specialist i Novo Nordisk A/S med globalt ansvar for DFP CU teknologi netv沫 samt support af CU produktionsenheder. Produktioner, der skal v沥 i compliance med de europ橳ke sundhedsmyndigheder (EMEA), amerikanske FDA, samt den japanske- og kinesiske Pharmacopiea. Gode lederevner og stor erfaring med linieledelse (op til 40 ingeni岩 indenfor forskellige tekniske omr夥r s嶥l projektledelse som projekt komiteer. Godt strategisk overblik og forretningsforst奬se. CU Engineering er et enkeltmands firma, der samarbejder i et netv沫 af r大ivere, hvilket giver stor fleksibilitet med hensyn til projektleverancer. CU-Engineering har st沫e kompetencer indenfor proces- og udstyrsdesign, proces automation, udstyr og system installation, opstart og kvalificering (DQ/IQ/OQ/PQ).	Kernekompetencer: Projektledelse Subject Matter Expert Procesoptimering Mikrobiologisk uddannelse

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