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 Site Manager) phases 4-8 – preparation for plant shutdown
Sanofi
- GMP in a regulated environment.
- Covered all planning phases: feasibility study through preliminary and detailed design, permit and execution planning up to construction supervision / concept for managing external contractors.
- Developed concept for plant shutdown.
- Project volume €150M.
Jan 2022 - Dec 2023
2 yearsLead site management & project control
Eurofins
- GMP construction.
- Pharmaceutical manufacturing.
- Project volume €7.9M (phases 4-9).
Jan 2021 - Dec 2025
5 yearsSchwarzheide, Germany
Client representative
BASF- Air Liquide, Deutschland GmbH
- Industrial gases.
- Chemical plant for air separation.
- Approval for pharmaceutical manufacturing.
- BASF Schwarzheide project volume €128M (phases 7-9).
Jan 2020 - Dec 2022
3 yearsTendering and medical technology project management
Klinikum Region Hannover
- New ICU building, medical technology contract, project volume €8.7M.
- Phases 3-9.
- QA activities DQ, IQ (phases 4-9).
Feb 2017 - Sep 2019
2 years 8 monthsFrankfurt, Germany
Design Qualification (DQ)
University Hospital Frankfurt of Johann Wolfgang Goethe University
- Construction project House 23F GMP – GMP DQ and IQ.
- New pharmacy construction (LPH 9).
Oct 2014 - Dec 2018
4 years 3 monthsHeidelberg, Germany
Project management (LPH 1-9)
University of Heidelberg
- Pharmacy.
- IQ, pharmaceutical manufacturing.
- Risk areas: EN 14971.
Jan 2011 - Present
14 years 10 monthsIMS, Industrial Risk Management Representative
- Risk IMS plant engineering => GMP in a regulated environment.
- Plant design validation.
Aug 2008 - Oct 2014
6 years 3 monthsSwitzerland
Medical technology application developer
Air Liquide
- Medical devices market development in DACH.
- Special systems 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 10 monthsGermany
VOB/A and B acceptance and expert services
- Project management for public clients (LPH 5-9).
- Court-appointed expert at Saarbrücken Regional Court.
- Court-appointed expert for the State of Lower Saxony.
- Assumed owner's representation and construction management.
- Project control / objective management.
- Interface management.
- Preparation and review of tender documents.
- Cost control.
- Construction management, project management.
- Owner's representation in all service phases.
- Training in VOB/A and B.
- Training in VDMA 4390ff.
- Training in ISO 7396ff.
Jan 2004 - Dec 2023
20 yearsGermany
Freelance Projects
Project highlights:
- University of Heidelberg, process engineering LPH 1-8.
- University of Cologne, system analysis process engineering LPH 3-7.
- MHH Hannover, system analysis process engineering LPH 1-8.
- Linde Gases.
- Air Liquide Germany.
- Solvay Germany.
- SANA TGmed, system analysis process engineering LPH 2-6.
- Expert assessments as appointed court expert.
- Confidential/private assignments.
- Expert assessments as appointed private expert, confidential assignment.
- GNH Kassel, medical process engineering LPH 1-8.
- Märkische Clinics medical process engineering LPH 1-8.
- Vivantes Berlin, medical process engineering LPH 1-8.
- Clinics Region Hannover medical process engineering LPH 1-8.
- MG State of Lower Saxony.
- Vivantes Berlin - total LPH 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.
- Contract volume €15M (LPH 6-8).
Business Development, Lead Auditor QI Risk Projects, Construction and Project Management EMEA
Linde Gas Therapeutics, Linde Group
- Business development in the service & investment market environment.
- Marketing Europe / REC organization.
- Strategic positioning for business development.
- Development of medical and pharmaceutical construction.
- Direct reporting to the CEO Europe, contract volume €120M p.a.
Projects - plant construction for MHH - Hannover Medical School
State Construction Management Hanover
- Plant construction.
- Acceptance tests, project management of medical devices / cryo technology.
- VOB/B support for construction projects, contract volume €4.5M (LPH 8-9).
Languages
German
NativeEnglish
AdvancedPolish
AdvancedCertifications & licenses
Auditor ISO 13485
Authorized person for pressure vessels and piping according to Annex 2, Section 4, Number 3
BetrSichV
IMS, Industrial Risk Management Representative
Risk auditor for medical device construction, pharmaceutical manufacturing and qualification
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