Karl Senn

Basic

ist verfügbar. ✅

Bis 2020, Suche arbeit als Projektmanager / Q-Ingenieur, Auf der Suche nach neuer beruflicher Herausforderung

Bern, Switzerland

Skills

GDP + GMP
FAT to SOP all steps
CFR 21 Part 11
FMEA
FRA
Training
EN ISO13485 Intern Auditor
Projektmanagement
Cleaning validation
Cleaningprocess consulting for Pharma and Medical
Flexibilität
Technical background

Timeline

Professional experience for Karl Senn

  • Current 3 years and 3 months, since Aug 2018

    Projektmanager Verpackungstechnik

    CSL-Behring Bern

    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 €

  • Current 4 years and 1 month, since Oct 2017

    Projektmanager

    Belimed AG

    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.

  • 3 months, Jul 2020 - Sep 2020

    Suche arbeit als Projektmanager / Q-Ingenieur

    Auf der Suche nach neuer beruflicher Herausforderung

    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.

  • 1 year and 10 months, Feb 2016 - Nov 2017

    Validation Officer

    STAHL Metall und Medizintechnik GmbH

    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.

  • 1 year and 2 months, Sep 2016 - Oct 2017

    Coordinator and Development of UDI

    3M DACH

    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.

  • 1 year and 2 months, Sep 2016 - Oct 2017

    Projektmanager

    3M Dental (3M Espe)

    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.

  • 4 months, Nov 2015 - Feb 2016

    Validierungsbeauftragter

    extern für MEDIKOMP GmbH - Maquet / Getinge AB

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

  • 1 year and 6 months, May 2014 - Oct 2015

    Validation / Qualification engineer

    NSLF (Novartis)

    • 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

  • 9 years, Jun 2005 - May 2014

    Validation and Qualification engineer

    Abbott Ireland Diagnostic Division

    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

Educational background for Karl Senn

  • 2 years and 3 months, Sep 2010 - Nov 2012

    Quality Management

    Athlone Institute of Technology

    Quality management in production and process

  • 4 years and 2 months, Apr 1970 - May 1974

    Industrial Engineering

    Apprenticeship in mechanical design (degree level)

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

Languages

  • English

    Fluent

  • German

    First language

  • French

    Basic

  • Italian

    Basic

  • Romanian

    Basic

Wants

short- and longterm-contracts for Qualification and/or Validation within the pharamceutical Industry
german and englisch speaking areas preffered other areas considered
Project-Management
projects concerd with washers and/or autoclaves
projects in relation to primary packaging of liquids and powder
Projects in relation to UDI and secondary / tertiary packaging

Interests

Flying - Aviation
reading
Travelling

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