Raffaele Rotunno
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Bio
Experience
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Adept Group (Adept Packaging)
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United States
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Packaging and Containers Manufacturing
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1 - 100 Employee
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Jan 2019 - Present
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Jan 2016 - Dec 2018
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Adept Packaging | Manager - Serialization and Technology
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Jun 2016 - Feb 2019
MAIN TASKS Project management • Work Breakdown Structure • Detailed Project plan • Resource management • Risk register update • Task assignment and coordination • Vendor governance ADEPT PACKAGING SERVICES • Subject Matter Expert / Quality maintenance • Engineering and process analysis • IT workstream e ENG workstream User Requirements Specification • Training concept • Review Functional specifications and Design specifications • Support Uhlmann system developments (IT functionalities and equipment) • Deployment pilot line (manual packaging line + site server system) • Deployment rollout lines (25 automated secondary packaging lines) • Support installation activities on site • Documentation management and archiving • Execution of E2E validation / qualification activities on site • Support switch to Serialization production (monitoring PQ activities) • Standardization print and camera layouts for European markets • Creation and optimization of machine formats, printing formats and camera formats • Problem solving and system improvement (software configurations) Show less
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The Janssen Pharmaceutical Companies of Johnson & Johnson
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Adept Packaging | Sr. Engineering consultant - Serialization and Technology
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Oct 2014 - Jan 2016
MAIN TASKS (GLOBAL PROGRAM) • Analysis of international regulations' requirements • Development of core documentation (Global URS - labeling & equipment) • Support technical analysis for Print & Check solutions / Design review • Development of SKU listing and management system (LOCAL PROJECT - Janssen-Cilag S.p.A | Latina - Italy) • Site PM, project management support • Analysis of artwork and specification development (multi-level packaging) • Engineering workstream User Requirements Specification • Equipment configuration for variable data coding (i.e Saudi Arabia market) - 11 packaging lines • Support implementation of Serialization and Track & Trace systems - 5 packaging lines Show less
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Adept Group (Adept Packaging)
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United States
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Packaging and Containers Manufacturing
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1 - 100 Employee
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Adept Packaging | Engineering Consultant - Serialization and Technology
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Apr 2013 - Jun 2015
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Sandoz
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Adept Packaging | Engineering consultant - Serialization and Technology
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Jul 2013 - Sep 2014
MAIN TASKS (GLOBAL PROGRAM) • Support to Serialization and Track & Trace systems implementation (European area) • Analysis of international regulations' requirements • Development of core documentation • Cross-site technical assessment of packaging lines (China and S. Korea requirements) • Capital Appropriation Request preparation and review (LOCAL - Lek Pharmaceutica d.d. | Ljubljana - Slovenia) • Engineering and process analysis | Serialization SME • IT workstream and Engineering workstream User Requirements Specification • Support Antares system developments (ITfunctionalities and equipment) • Review Functional specifications and Design specifications • Development and review of Functional Risk Assessment • Review FAT protocols • Support functional tests execution Show less
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Education
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University of Rome Tor Vergata
Master's degree, Industrial Engineering and Management -
NEWI Glyndwr University
Attendance certificate, Industrial Engineering and Management -
University of Rome Tor Vergata
Bachelor Degree, Industrial Engineering and Management