Thermo Fisher Scientific: Equipment Lead
2 giorni fa
SCOPO DELLA POSIZIONE/RESPONSABILITA':
Assicurare adeguato supporto nell’introduzione di nuovi impianti e nuove macchine, nell’ambito dei progetti di sito, in collaborazione con Ingegneria e Servizi Tecnici.COMPITI SPECIFICI/ATTIVITA' PRIMARIE:
Requisiti UtentePreparare i documenti di requisiti utente per nuovi impianti ed equipment, in collaborazione con gli utenti finali. Interfacciarsi con i fornitori per le necessarie discussioni tecniche nelle fasi di progettazione, costruzione, installazione finale e qualifica.Analisi della documentazione técnicaAnalizzare e rivedere la documentazione técnica (specifiche di progetto, specifiche funzionali, specifiche software e hardware) fornita a corredo dei nuovi equipment.Supporto agli utentiSupportare gli utenti finali nel passaggio dalla fase di installazione alla fase operativa dei nuovi equipment. Fornire supporto nella preparazione delle procedure di utilizzo e gestione, nonché nell’esecuzione dei training per l’utilizzo dei nuovi sistemi; supportare l’implementazione dei change di introduzione degli equipment. Inoltre, fornire adeguato supporto, laddoverichiesto, nella preparazione della documentazione necessaria per la sottomissione agli enti regolatori.RapportiInterni principalmente con reparti di Ingegneria, Servizi Tecnici, Produzione, Validazione, Computer System Validation (CSV); esterni con Fornitori eClientiREQUISITI E QUALIFICHE:
A) Essenziali:
Studi/Diplomi/Corsi di formazione:
Laurea a indirizzo tecnico/scientifico o comprovata esperienzaConoscenze tecniche e informatiche:
Conoscenza delle cGMPConoscenza delle normative riguardanti i requisiti specifici degli Equipment e delle Utilities in ambito farmaceuticoUtilizzo di Word, Excel, MS ProjectEsperienze professionali:
Esperienza di almeno 2-3 anni in progetti di implementazione di impianti e utilities in aziende di produzione di farmaci. Esperienza e conoscenze specifiche sulla implementazione di macchine di visual inspection automatica, dalla fase di configurazione alla qualificaLingue:
Buona conoscenza dell’IngleseTratti di personalità:
Capacità organizzativeCapacità di interazionePropensione al lavoro di gruppo(b) Desiderabili:
Conoscenza técnica/ingegneristica degli impianti di produzione farmaci sterili.
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