C + Q Solutions
| Since 09/2019 | Support for several small projects – part time |
| 12/2018 – 08/2019 | Interim Director Engineering – Dynavax GmbH |
| 04/2017 – 10/2018 | Basic/Detail Design support, qualification management (FAT/SAT) for a complete pharmaceutical Multi-use Downstream line in South-Korea |
| 02/2016 – 01/2017 | Project manager for rebuilding two microbial fermenters for commercial production / Project Manager for implementation of a Siemens WinCC SCADA system, at Dynavax GmbH, Germany |
| 10/2014 – 02/2016 | Project manager for implementation of new Clean Utilities (PW,WFI,CS), clean room rebuild and new autoclaves and parts washers, at Dynavax GmbH, Germany |
| 04/2013 – 07/2014 | Development of a qualification concept, Detail Design, supervision of FAT/SAT for a complete pharmaceutical Multi-use and Single-Use (Hybrid) facility in South Korea |
| 11/2012 – 03/2013 | Detail Design and execution of rebuilding a cell culture bioreactor for commercial production at CMC Biologics, Copenhagen, Denmark |
| 04/2011 – 10/2012 | Basic/Detail Design support, FAT/SAT and qualification management, development of a qualification concept for a complete Single-Use factory in China |
| 11/2010 – 03/2011 | Qualification of a Single Use Bioreactor production line and a 200L autoclavable fermentation unit for Sartorius Stedim Systems |
| 06/2010 – 10/2010 | Qualification of a Single Use Bioreactor production line at CMC Biologics, Copenhagen, Denmark |
| 01/2009 – 05/2010 | Project manager for rebuilt of a cell culture line / Rebuild and improvements, including engineering and qualification, of existing production equipment / Creation of a maintenance database at CMC Biologics, Copenhagen, Denmark |
| 06/2008 – 12/2008 | Work package owner “process upstream equipment” for basic design of a new production plant at CMC ICOS Biologics, Seattle, USA |
| 06/2007 – 06/2008 | Project management und Integrated Commissioning and Qualification for two new cell culture lines at CMC Biopharmaceuticals, Copenhagen, Denmark |
| 06/2007 | Establishment of C + Q Solutions |
Professional Experience
| 04/2004 – 05/2007 | Qualification Engineer, Sartorius BBI Systems GmbH (formerly B.Braun Biotech International GmbH), Melsungen, Germany Tasks: Lead engineer for testing and qualification of biotechnological – pharmaceutical process equipment: |
| Project Management and Quality related coordination: NVI: Vaccine productions lines; Netherlands | |
| Project Management and Quality related coordination: Roche Diagnostics: Biologics IV production line, Germany | |
| Coordination and execution of IQ/OQ: CMC Cell culture and microbial production lines, Denmark | |
| Coordination and execution of FAT: Merial: Vaccine production line at Sartorius BBI Systems Milano, Italy | |
| Coordination and execution of FAT: GSK production line, Belgium |
Work Experience during Studies
| 08/2002 – 05/2003 | B.Braun Biotech International GmbH, Task: Collaboration in qualification of process equipment, Novo Nordisk Factor VII Plant in Hillerød, Denmark |
| 02/2002 – 06/2002 | B.Braun Biotech International GmbH, Task: Calculation and dimensioning of heat exchangers for bioreactors |
Education
| 1997 – 2004 | Study of Mechanical Engineering Universität Kassel, Kassel, Germany Degree: Graduate Engineer – Mechanical Engineering |
| 1993 – 1996 | Grammar school with focus on practical and theoretical training in Mechanical Engineering Berufliche Schulen des Werra-Meißner-Kreises, Witzenhausen,Witzenhausen, Germany Degree: University-entrance diploma |
Languages
| German, English (business fluency), Danish (basic communication skills) |
Professional Trainings / Workshops
| 2014 | ISPE | Conference: Roughing at stainless steel |
| 2011 | PDA | Workshop: Single-Use Systems |
| 2011 | ISPE | Workshop: Single-Use Systems |
| 2011 | Sartorius | Classroom training: Configuration of DCU systems |
| 2009 | ISPE | Online conference: GAMP Changing the Industry |
| 2008 | ISPE | Conference: Project Management |
| 2007 | VDMA | Conference: Sterile process engineering |
| 2007 | ISPE | Conference: Pharmaceutical manufacturing |
| 2007 | ISPE | Classroom training: Application of Commissioning and Qualification |
| 2007 | VDMA | Workshop: Development of a standard for the Riboflavin test |
| 2006 | TÜV Süd | Classroom training: European pressure equipment directive |
| 2006 | ISPE | Conference: Good Engineering Practices and Equipment Qualification |
| 2006 | VDMA | Conference: Sterile process engineering |
| 2004 | PTS Training Service | Classroom training: Equipment qualification and process validation in compliance with GMP |