Jan K.
GMP consulting as expert (phases 1-9)
Experience
May 2024 - Apr 2025
1 yearWarngau, Germany
GMP consulting as expert (phases 1-9)
AMW GmbH
Apr 2024 - Aug 2024
5 monthsActing (Senior Construction Manager) (phases 4-8) - plant shutdown preparation
Sanofi
- GMP in a regulated environment.
- Took on all project phases: basic evaluation through preliminary & design planning, approval & execution planning to construction supervision / subcontractor management concept.
- Developed concept for plant shutdown.
- Project volume €150M.
Jan 2022 - Dec 2023
2 yearsMain site management & project control
Eurofins
- GMP construction.
- Pharmaceutical manufacturing.
- Project volume €7.9M (phases 4-9).
Jan 2021 - Dec 2025
5 yearsSchwarzheide, Germany
Owner's representative
BASF- Air Liquide, Deutschland GmbH
- Industrial gases.
- Chemical plant for air separation.
- Licensed for pharmaceutical manufacturing.
- BASF Schwarzheide project volume €128M (phases 7-9).
Jan 2020 - Dec 2022
3 yearsTendering, project management medical technology
Klinikum Region Hannover
- New ICU building, medical tech contract, project volume €8.7M.
- Phases 3-9.
- QM activities: DQ, IQ (phases 4-9).
Feb 2017 - Sep 2019
2 years 8 monthsFrankfurt, Germany
Design qualification (DQ)
Universitätsklinikum Frankfurt der Johann Wolfgang-Goethe-Universität
- Building project House 23 F GMP – GMP area DQ, IQ.
- New pharmacy (phase 9).
Oct 2014 - Dec 2018
4 years 3 monthsHeidelberg, Germany
Project management (phases 1-9)
Uni Heidelberg
- Pharmacy.
- IQ, pharmaceutical manufacturing.
- Risk areas: EN 14971.
Jan 2011 - Present
14 years 8 monthsIMS, Industrial Risk Management Representative
- Risk IMS plant construction => GMP in a regulated environment.
- Plant design validation.
Aug 2008 - Oct 2014
6 years 3 monthsSwitzerland
Application developer medical technology
Air Liquide
- Market development medical devices DACH.
- Special equipment for ultra-pure gases.
- Market launch.
- CE compliant systems for medical devices.
- Transformation of sales concept.
- Business development DACH.
- Customer process and analysis.
Jan 2004 - Present
21 years 8 monthsGermany
VOB/A / B acceptance & expert services
- Project management for public clients (phases 5-9).
- Appointed expert at Saarbrücken Regional Court.
- Appointed expert for Lower Saxony.
- Took over owner's representation and site management.
- Project control / goal management.
- Interface management.
- Preparation and review of tender documents.
- Cost control.
- Site management, project management.
- Owner's representation in all phases.
- Training on VOB/A and VOB/B.
- Training on VDMA 4390ff.
- Training on ISO 7396ff.
Jan 2004 - Dec 2023
20 yearsGermany
Freelance projects
Excerpt of projects:
- University of Heidelberg, plant engineering phases 1-8.
- University of Cologne, system analysis plant engineering phases 3-7.
- Hannover Medical School, system analysis plant engineering phases 1-8.
- Linde Gases.
- Air Liquide Germany.
- Solvay Germany.
- SANA TGmed, system analysis plant engineering phases 2-6.
- Expert activities as appointed court expert.
- Confidential/private assignments.
- Expert activities as appointed private expert, confidential assignment.
- GNH Kassel, medical plant engineering phases 1-8.
- Märkische Clinics, medical plant engineering phases 1-8.
- Vivantes Berlin, medical plant engineering phases 1-8.
- Clinics Region Hanover, medical plant engineering phases 1-8.
- MG Lower Saxony.
- Vivantes Berlin – complete phases 1-9.
Jan 2001 - Dec 2022
22 yearsHanover, Germany
Leadership role for MHH
State Construction Management Hanover
- DQ, IQ pharmaceutical manufacturing.
- Risk areas, manufacturing, validation.
- Project volume €15M (phases 6-8).
Business Development, Lead Auditor QI Risk Projects, construction and project management EMEA
Linde Gas Therapeutics, Linde Group
- Business field development in the services & investment market.
- Marketing Europe / REC organization.
- Strategic positioning of business development.
- Development of medical and pharmaceutical construction.
- Direct reporting to the CEO Europe, project volume €120M p.a.
Projects - plant engineering for MHH - Hannover Medical School
State Construction Management Hanover
- Plant engineering.
- Acceptances, project management medical devices / cryo technology.
- VOB/B support for construction projects, project volume €4.5M (phases 8-9).
Languages
German
NativeEnglish
AdvancedPolish
AdvancedCertifications & licenses
Auditor ISO 13485
Qualified person for pressure vessels and piping according to Annex 2, Section 4, Number 3
BetrSichV
IMS, Industrial Risk Management Representative
Risk auditor for medical plant engineering, pharmaceutical manufacturing and qualification
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