On this page I want to give you an impression about my education and previous experience in professional life

Education

University Qualification

The general qualification for University entrance I have acquired at the Winfriedschule Fulda, a secondary school of the district of Fulda

 

Studies

I gained my skills in the study of Biotechnology at the Fachhochschule Gießen. The degree program has been established in this time and I am specialized in the field of Bioprocess Engineering with a special view of Microbiology and Pharmacokinetics. In the field of Bioprocess Engineering I completed my thesis.

 

Thesis

Measurement of viscosity and oxygen transfer coefficient in non – newtonian fermentation fluids

Professional Activities

The rheological behavior of fermentation fluids is very important for biotechnological processes. As an application engineer for rheological instruments I was responsible for a laboratory with scientific measuring devices, online rheometer and devices for quality control. I was able to gain valuable professional experience on the experimental design and execution, as well as knowledge about the application and use of various instruments.

 

 

The employment at a pharmaceutical company was associated with the specific expectation to optimize the technology in the compounding area to provide sterile nutrition media for a successful execution of media fills on the machines. In addition, I was responsible for the qualification and validation of the systems. I could use my expertise in the field of bioprocess engineering and microbiology for the development of aseptic drug manufacturing processes.

 

I was head of the process validation teamat a manufacturer of packaging lines for liquid pharmaceuticals. As part of this activity I was as a leader of large qualification projects in charge of the budget. During the development phase of new machines I was responsible to implement validation requirements, this is particularly important for aseptic processes and biodecontamination.

 

 

Language Skills:

German and English

Skills and experiences are present in the following fields:

  • Project Management Validation.
  • Aseptic Manufacturing of Pharmaceuticals.
  • Barrier Isolation Technology
  • Sterilization- und depyrogenization processes
  • Bio decontamination processes
  • Pharmaceutical water and sterile filtration
  • Monitoring of manufacturing processes (biological, chemical und physical)
  • Biological and chemical analytics
  • Qualification, Validation und mediafill
  • Clean rooms
  • Low Energy Electron Beam irradiation
  • Consultancy for OOS Results of pharmaceutical processes.
  • Lectures at national and international Conferences

Leadership and responsibilities for:

  • Process Validation Team
  • Representing the Head of Validation
  • Training for Isolation Systems
  • Development of new Products and Services
  • Coordination and Management of external Serviceproviders
  • Supervision and maintenance of compounding equipment, WFI and clean steam systems
  • Technical support for development of aseptic manufacturing processes for liquid drugs

Training

Management

  • Leadership - project management 2002
  • Project 2002 Organization 2006
  • Leadership - project management 2009
  • Export Control 2010
  • Rapid Assessment and Recovery of Troubled projects 2012
  • Deviation Management and CAPA 2013
  • Compliance – Code of Business Conduct 2013
  • Export Control 2013
  • Antitrust Law 2013

Professional

  • Measurement on disperse liquid systems during development, production and quality control 1991
  • GMP workshop for liquid systems 1993
  • GMP Workshop for employees in technical facility departments of drug companies 1994
  • Filter Integrity testing certification course 1995
  • Actual hygienic standards in drug companies - GMP-workshop 2001
  • Validation on Isolators for pharmaceutical production 2002
  • Application and Validation of microbiological Testing Methods 2004
  • PAT in Microbial QC - Rapid Methods 2006
  • Conference Pre-sterilized Syringes 2007
  • Barrier Isolation Technology Conference 2007
  • Low Energy Electron Beam Irradiation 2008
  • Aseptic Processing Media Fill 2009
  • GAMP 5 Conference 2009
  • Barrier Isolation Technology Conference 2011
  • Rapid Microbiological Methods Conference 2011
  • Pharma Congress Production & Technology 2012
  • Cleanliness of Medical Devices, production hygiene, final cleaning and Monitoring 2015
  • Decontamination of safety cabinets, Filters and Clean Rooms with vaporized H2O2 (VHP) 2016

 

 

 

More information about Reference projects can be viewed at References.
Availability can be seen here.
(Please ask for your password via contact form)

 

 

Bibliography:

 Pictures:

1. angellodeco / www.shutterstock.com

2. Zbynek Jirousek / www.shutterstock.com