Arne Sandrock C+Q Solutions

C + Q Solutions

Since 04/2017 Basic/Detail Design support, qualification management (FAT/SAT) for a complete pharmaceutical Multi-use Downstream line in South-Korea
02/2016 – 02/2018 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