Validation Engineer developing documentation for commissioning and validation of pharmaceutical facilities in Italy. Requires travel in Italy and occasionally in Europe, with a focus on compliance and GMP.
Responsibilities
Supportare la documentazione per il commissioning, la qualificazione e la validazione delle strutture farmaceutiche, utilities ed equipaggiamenti
Esecuzione e reporting dei protocolli di qualificazione degli isolatori
Redazione e esecuzione dei protocolli, verifica sul campo e sviluppo di report di sintesi presso i siti dei clienti
Requirements
Almeno 3 – 5 anni di esperienza in attività di commissioning e/o qualification in un'industria regolata dalla FDA
Laurea BS o MS in un campo scientifico o ingegneristico pertinente, o anni equivalenti di esperienza pratica
Conoscenza approfondita dell'applicazione dei principi GMP
Eccellenti capacità di problem solving tecnico e troubleshooting
Disponibilità di viaggiare in tutta Italia e talvolta in Europa.
Benefits
Disponibilità a fare trasferte sia in Italia che all'estero
Selezione rispetta il principio delle pari opportunità (l. 903/77)
Job title
Validation Engineer – Isolators, VHP Cycle Development
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