Karl Senn

Introduction and implementation of a new, thermoforming packaging machine for the non-sterile area and a similar one for the clean room ISO class 7. Management of all aspects between building up to qualification. Due to hiring-stop is the present contract not extended and the current project partially stopped. Developing of thermoformed packaging.Introduction and implementation of a new, thermoforming packaging machine for the non-sterile area and a similar one for the clean room ISO class 7.

Nachdem das Projekt an seinen dritten geplanten Standort verschoben wird, der Standort aber erst in 2021 Bezugsbereit sein wird und in der Zwischenzeit am jetzigen Arbeitsort keine Alternative Arbeit zur Verfügung steht, bin ich auf der Suche nach einer neuen Herausforderung. Ich stehe ab dem 01 Juli 2020 zur Verfügung für Projekte mit einer Dauer von 6 bis 12 Monaten, eventuelle mit der Option auf Verlängerung, im Deutschsprachigen Raum oder in meiner heimat Irland zur Verfügung.

Projekt-Manager für eine Hochgeschwindigkeitsverpackungsmaschine welche den Bereich De-palettieren, Sekundärverpackung und Tertiärverpackung gefolgt von Palettieren, sowie der Etikettenbedruckung und Etikettenapplikation auf allen Stufen. Vollautomatischer Umstellung zwischen verschiedenen Verpackungsgrössen, Produktinformationen und Etikettenabmessungen. Alles zusammen 21.11 konform und mit vollautomatischem. elektronischem Batchreport. Projektumfang 10+ Mio €

Manage different washer projects of different levels parallel to each other. Advise customer on process and equipment and coordinate the individual departements to achive customer satisfaction. Support producrtion, installation, FAT-SAT-IQ-OQ as well as maintence engineers.

Advice in regard to validation and qualification Revise and restructure the documentation system to reduce the burden on the factory as Stahl no longer assembles and introduces medical goods to the market but restricts itself to the production of the individual parts which then are delivered to the individual companies.

Introduction of UDI in Primary as well as secondary packaging. Sourcing of Equipment and support of installation. Where necessary developing new labels and introduction of new labelling techniques in teight relationship with Printer-producers, printer-supply-suppliers and packaging companies.

Develop and upgrade machinery to apply UDI Barcodes as per GS 1 on to syringes, blisters, tubes, jars and bottles as well as their different packaging levels. Sourcing of relevant technologies, testi and implement them. Indepht knowledeg of different marking techniques as for example laser-scribe, laser induced color change, thermo transfer on high speed packaging.

Responsible for process validation, leading qualification of new medical devices and auditing internal production processes

• Train suppliers and internal personnel on GDP (26 suppliers all over Europe and >35 internal engineers of different companies) • Participating in commissioning activities and supervising and inspecting filled in documents for GDP correctness. • Writing protocols and reports for FAT, SAT, IQ, OQ incl URS, FRA, DR and DQ

Qualification of Liquid- and powder fillers, Lab-equipment and Cleaning validation, Writing of all relevant documentation incl. SOP's, Training of operators. Sourcing and qualifying suppliers. FMEA + CAPA

Quality management in production and process

Vessels, filters, coaters and mixers for the pharmaceutical industry, Power plants for process steam and heating