„Your solution partner with special know-how and wide knowledge“

Profile

  • Successful since 2002 as Project Manager, Validation Manager, Test Manager
  • Active in the field of medical technology and pharmaceuticals with laboratory systems, insulin pumps and blood glucose meters.
  • Project duration from 1 month to 3 years
  • From solo project to management of project teams with up to 25 employees
  • Verification and Validation
  • From small devices and test stations to laboratory systems MES / LIMS
  • Embedded Computing and High-level Language
  • Mobile Computing and Client-Server

Education:
Computer Science at the University of Oldenburg

 

Jens Burkert

Expertise
  • Test management
  • Project management
  • Verification (FDA)
  • Validation of computerized systems CSV (GAMP 5)
  • Manual and automatic testing of software
  • Requirements engineering
Database
  • SQL
  • IRD DB sds
  • dBase
Programming Languages
  • C, C++, C#
  • Microsoft Visual Basic and VBA
  • Java
  • Pascal, MODULA 2, Cobol
  • Assembler
Standards/guidelines
  • FDA 21 CFR Part 11, 820, 510k
  • ISO 13485
  • Eudralex Annex 11, 15
  • GAMP 5
  • V-Modell
Operating Systems
  • MS Windows
  • Sun Solaris
  • Unix
  • BS2000
Tools
  • Rational Tools: Rational RequisitePro, ClearQuest
  • Jira
  • HP QC (Mercury)
  • Windream
  • X-Windows (Unix)
  • MES
  • LIMS

Certificates

Further education

The Goal

The best possible solution
for your project.
To ensure quality, be on schedule
and within budget.

The Way

Project management as
part of your team and
validation management within
company and legal regulations

The Approach

Structured,
solution oriented,
pragmatic.