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Curriculum Vitae
Dipl.-Ing. Dr. techn.
Siegfried Proyer

Physicist and Consultant Pharma IT with experience in R&D, IT quality management, pharmaceutical manufacturing, working in global enterprise environments. Born 1967 in Linz [Austria] Married to Elke Stangl Motto: The early bird catches the worm The current version of this CV can be found at punktwissen.at/sigi/

Career
Since 2006 Consultant Pharma IT and Managing Partner punktwissen proyer & stangl OG. Focus: MES implementation projects at European pharmaceutical companies, validation documentation, business processes in pharmaceutical manufacturing. Since 2006 PAS-X Consultant Werum Software and Systems [Germany]. Support of MES projects as a subcontractor of MES supplier. 2003-2005 Head of Department IT Systems & QM Development of corporate QM IT guidelines, MES implementation at international production sites. Responsible for a team of 4 IT specialists. 2001-2003 Head of Department Quality Management IT Development of QM for IT systems at Vienna site. Requirements analysis, specification and validation of IT systems, development of SOPs [Standard Operating procedures]. 2 direct reports. Setup of QM IT department. 2001 IT Manager for Manufacturing Division Octapharma. Implementaton of MES at Vienna site for manufacturing of blood plasma derivates. 1998-2001 Trainee in Manufacturing Division Octapharma Pharmazeutika Prod.ges.m.b.H, Vienna. Analysis of processes in logistics and manufacturing, pharma IT systems support and design. Automation SPS, SCADA. 1997-1998 Researcher and Project Manager Austrian Research Centers Seibersdorf, Division Materials Research, Center for Microcharacterization. Contract research for steel industry, analysis and optimization of steel microstructure. EU and national projects. 1996-1997 Contract Researcher at the Austrian Research Centers Seibersdorf, Division for Materials Research: Development of setup for measuring optical material properties, automation. 1992 R&D Visit at NKT Research Center, Copenhagen [Denmark] 1992-1996 Researcher at the University of Linz, Department of Applied Physics, national and EU R&D projects, laser material processing, superconductivity, deposition and patterning of thin films, measurement of electrical, optical and structural material properties. Development of experimental setups for pulsed laser deposition and automated measurements of electrical properties at low-temperatures. 1990-1995 Lecturer [Linz] Lectures, labs, exercises, tutorials: fundamentals of physics, modern optics, high temperature superconductivity, laser material processing. Coaching of diploma students.

Professional Experience
Pharmaceutical Manufacturing processes in manufacturing of blood plasma derivatives, liquida, tablets. Logistics, supply chain management, material flow, goods reciept, storage, single donation control, plasma fractionation, weighing and dispensing, manufacturing execution, packaging, shipping, traceability Best Practices for modelling of business processes in pharmaceutical manufacturing and implementation of pharma IT systems. Validation concepts development and review, validation documents: Validation plan, user requirements specification [URS], risk analysis, business process documentation, test specification IQ, OQ, PQ, validation reports. Quality Management development and maintenance of QM-Systems for pharma IT, Computer System Validation, change management, preparation for inspections [e.g. FDA], QM best practices, pragmatic implementation of QM systems. Establishing and controlling compliance with pharma industry standards GAMP, GMP - Good [Automated] Manufacturing Practice, 21CFR Part 11 [FDA] [International] Project Management Planning, implementation, migration and upgrades of pharma IT systems, go-live support, cut-over planning, year 2000, R&D projects [development of materials and technologies], international cooperations, contract research Pharma IT Systems MES [Manufacturing Execution System]: Werum PAS-X, ERP [Enterprise Ressource Planning]: SAP, GEAC System 21, LIMS [Laboratory-Information Management System], automation [PLC, SCADA], monitoring systems, database systems, interfaces [e.g. MES-ERP], intranet, operation of IT-systems, migration, contingency planning. Management of department Accountability for budget, forecasting, people management, setup of new business unit, working as middle manager in corporate [international] environment. Member of the international PAS-X User Forum Active User Group, Development of best practices for the manufacturing execution system PAS-X Documentation, Publications system documentation, validation documentation, project plans, QM documents [guidelines, SOPs, policies], scientific publications, lectures Teaching, Training Basics and advaced topics in physics, quality management, user training, training-on-the-job, supervisor of master students Physics, Natural Sciences fundamentals [physics, chemistry, mathematics], laser physics, optics, solid state physics, theoretical physics, superconductivity, quantum statistics, gas dynamics. R&D Applied Physics and Materials Science design and implementation of experimental setups, [Excimer] laser technology, materials development, high temperature superconductors, steels, films and coatings, pattering of thin films, vacuum technology, measurement engineering, electrical and optical material properties, micro-structural investigations [TEM, SEM, EDX], image analysis, automation.

Education, Qualifications, Awards
1992 and 1996 Award for exceptional achievements by the Austrian Ministry of Science. 1995 Doctoral examinations with distinction Promotion sub auspiciis praesidentis 1996. 1992-1995 PhD Studies, Doctorate in Technical Sciences Thesis: 'Pulsed-Laser Deposition of High Temperature Superconducting Thin Films - Fundamentals and Technology'; [in English] 1991 Master thesis at the Department for Applied Physics - "Patterning of Thin Films of the High Temperature Superconductors YBCO and BISCO" [in German] 1987-1992 Studies Technical Physics Johannes-Kepler-University of Linz. Basics: physics, mathematics, chemistry. Focus: solid state physics, laser physics, optics, high temperature superconductivity, gas dynymics, quantum statistics. Final exams with distinction. 1986-1987 Military service One year volunteer' training for military officers, lieutenant [1990]. 1980-1986 High school in Linz, focus on natural sciences, final exam with distinction Languages English [daily business and technical conversation], French [basics] Driving Licence A, B

Hobbies and Other Interests
Physics and society sustainability, renewable energy Do-it-yourself Running and fitness in general Digital photography and video filming Guitar

Links
PAS-X User Forum 2007 TalkOctapharma fractionation of human plasma www.octapharma.comSeibersdorf Austrian Research Centers Seibersdorf - Materials Science www.materials-technology.atScientific Publications University of Linz and Research Center Seibersdorf Search Results scholar.google.comScientific Roots Department of Applied PhysicsUniversität Johannes Kepler University of LinzEPSI Somebody epsi.namePrivate website: z-village stories of 'somebody': not to be taken seriously z-village.net


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