Validation specialist

Act as a strategic partner, providing value-added solutions, developing and implementing hands-on measures in order to realize the required process improvements and ultimately improve margins; Drive changes and efficiencies by recommending new ways to operate, contributing actively to their actual implementation and providing feedbacks; Build realistic and comprehensive action plans to reduce cost, increase quality and improve service level; Participate at meetings with Automation department in order to define the technical requirement specifications for new equipments considering R&D, QA and Operations requests; Define, execute and validate the production process of new product in collaboration with R&D; Define, write and update production manual (MOP) and guarantee the quality for the entire process; Transfer production process; Execute process changes related to: methods, parameters and material changes; Execute Operational Qualification (OQ) and Performance Qualification (PQ); Execute equipment and production validation using statistical tools such us Gage R&R, Capability analysis, DOE, Regression, Hypothesis tests and others. Promote process improvements using Lean Six Sigma Approach.Multinational Company leader in medical devicesGreat Growth OpportunityGood English level (B1 Level) Management of the validation documents necessary for the process control and improvement and deep knowledge of validation strategy (IQ - OQ - PQ); Knowledge and experience with statistical tools: DOE study, Gage R&R, Capability analysis (Cp, Cpk, Pp, Ppk), sampling size definition preferably by means Minitab sw. Degree in Engineering Green Belt Certification will be a plusAt least 2-3 years of experience holding position in process engineering dept.Multinational Company leader in medical devicesGreath Growth Opportunity

LA RISORSA UMANA.IT SRL Divisione Recruitment ricerca Per azienda del settore biomedicale si ricerca un VALIDATION SPECIALIST con buona conoscenza della lingua inglese. La risorsa si occuperà di: -Effettuare studi di qualificazione e di convalida per i processi produttivi, le attrezzature e i servizi di pubblica utilità. - Fornirà assistenza tecnica, se necessario, per la risoluzione dei problemi di produzione e di ingegneria. - Sarà il responsabile del coordinamento delle attività di supporto alla validazione(come test di laboratorio) e della garanzia che la necessaria documentazione di progetto sia completa e accurata. - Valutare i progetti di qualificazione e validazione per stabilire protocolli e piani di prova tecnicamente e scientificamente validi. - Eseguire i protocolli eseguendo i test preapprovati nelle aree operative e di laboratorio. - Redazione di P-FMEA. - Raccogliere e analizzare tutti i dati, scrivere il rapporto finale e ottenere le approvazioni. - Esaminare la documentazione tecnica per verificarne la continuità e la precisione. - Valutare, mantenere e gestire la strumentazione di validazione necessaria per sostenere i progetti assegnati. - Stabilire e gestire i rispettivi piani di validazione allineando, coordinando e supervisionando la priorità delle attività rispetto alle esigenze aziendali. Esaminare le valutazioni dei rischi per la convalida. - Impostare procedure e modelli locali per la documentazione di validazione e il piano generale di validazione, fornire linee guida per la valutazione dell'impatto delle strutture e della criticità dei componenti. - Collaborare con Quality sulla base di feedback (ad esempio attraverso la divisione, ispezioni normative, modifiche normative) per stabilire e mantenere un approccio comune e tradurlo per il sito. - Mantenere tutte le attività in uno stato di pronto per l'ispezione prima di qualsiasi audit interno o esterno per garantire il buon esito delle ispezioni, ad esempio, nessu

The Process Engineering Specialist brings operations-expertise to help the organization in order to optimize production processes and realize substantial efficiency and cost saving. Act as a strategic partner, providing value-added solutions, developing and implementing hands-on measures in order to realize the required process improvements and ultimately improve margins; Drive changes and efficiencies by recommending new ways to operate, contributing actively to their actual implementation and providing feedbacks; Build realistic and comprehensive action plans to reduce cost, increase quality and improve service level; Participate at meetings with Automation department in order to define the technical requirement specifications for new equipments considering R&D, QA and Operations requests; Define, execute and validate the production process of new product in collaboration with R&D; Define, write and update production manual (MOP) and guarantee the quality for the entire process; Transfer production process; Execute process changes related to: methods, parameters and material changes; Execute Operational Qualification (OQ) and Performance Qualification (PQ); Execute equipment and production validation using statistical tools such us Gage R&R, Capability analysis, DOE, Regression, Hypothesis tests and others. Promote process improvements using Lean Six Sigma Approach.Medical DevicesGreat growth opportunityGood English level (B1 Level) Management of the validation documents necessary for the process control and improvement and deep knowledge of validation strategy (IQ - OQ - PQ); Knowledge and experience with statistical tools: DOE study, Gage R&R, Capability analysis (Cp, Cpk, Pp, Ppk), sampling size definition preferably by means Minitab sw. Green Belt Certification will be a plus Degree in Engineering At least 4-5 years of experience holding position in process engineering dept.Multinational Company leader in medical devicesGreat growth opportunity