Jan Kocma - GMP Consulting Expert

Hanover, Germany

Experience

May 2024 - Apr 2025

1 year

Germany

GMP Consulting Expert

AMW GmbH

Project phases 1–9 in GMP consulting
Advising and supporting investment projects in a regulated environment

Apr 2024 - Aug 2024

5 months

Germany

Acting Senior Construction Manager

Sanofi

Preparation for plant shutdown
Taking over all phases from basic assessment, preliminary and detailed planning to approval and execution planning
Construction supervision and concept for subcontractor management
Developing the shutdown concept
Project volume: €150M

Jan 2022 - Dec 2023

2 years

Germany

Lead Construction Management & Project Control

Eurofins

Construction supervision and project control in GMP construction
Project phases 4–9
Project volume: €7.9M
Planning and overseeing pharmaceutical production facilities

Jan 2021 - Dec 2025

5 years

Germany

Owner's Representative

BASF-Air Liquide Deutschland GmbH

Construction of chemical plants and air separation units in the industrial gas sector
Approval of pharmaceutical production facilities
Project volume: €128M (phases 7–9)
Project planning and coordination in industrial plant construction

Jan 2020 - Dec 2022

3 years

Hanover, Germany

Medical Technology Project Manager

Klinikum Region Hannover

New ICU (intensive care unit) construction
Tendering and project management for medical technology (phases 3–9)
Quality management measures for DQ and IQ

Feb 2017 - Sep 2019

2 years 8 months

Frankfurt, Germany

Design Qualification (DQ)

University Hospital Frankfurt (Johann Wolfgang Goethe University)

Construction project House 23 F in the GMP area
Design and installation qualification (DQ, IQ)
New pharmacy construction (work phase 9)

Oct 2014 - Dec 2018

4 years 3 months

Heidelberg, Germany

Project Manager Pharmacy

Heidelberg University

IQ and pharmaceutical manufacturing processes
Risk management according to EN 14971
Work phases 1–9

Jan 2011 - Present

15 years 1 month

Industrial Risk Management Representative

IMS

Responsible for IMS in plant engineering in regulated environments
Plant design and validation

Aug 2008 - Oct 2014

6 years 3 months

Germany

Medical Technology Application Developer

Air Liquide

Market development for medical devices in the DACH region
Special systems for ultra-pure gases
Market launch and CE-compliant systems for medical devices
Adaptation of sales concepts
Business development and customer process analysis

Jan 2004 - Present

22 years 1 month

VOB/B Expert and Owner's Representative

Self-employed

Acceptance tests according to VOB/B and expert services
Project management for public clients (work phases 5–9)
Owner's representation and construction supervision
Review of contract documents and cost control
Interface management

Jan 2001 - Dec 2022

22 years

Hanover, Germany

DQ/IQ Specialist for Pharmaceutical Manufacturing

State Construction Management Hanover

Design and Installation Qualification (DQ, IQ)
Risk assessment and validation of pharmaceutical facilities
Project phases 6–8
Contract volume: €15 M

Business Development

Linde Gas Therapeutics (Linde Group)

Business development in the services and investment market environment
Marketing Europe and REC organization
Strategic positioning and business development
Lead Auditor for QI risk projects
Construction and project management EMEA
Direct reporting to the European CEO
Contract volume: €120 M p.a.

Skills

Plant Engineering And Pharmaceutical Production.
Industrial Construction, Special Installations And Medical Technology.
Technical Pressure Systems For High Purity Gas Technology Up To 7.0.
Gmp Investment Projects, Site Supervision, Project Planning.
Coordination And Organization Of Structural And Civil Works, Labs And Clean Rooms.
Designing And Overseeing Construction Plans To Meet Planned Timelines.
Monitoring Progress And Calculating Costs For Construction Sites.
Coordinating Official Inspections And Approvals.
Recruiting Staff For Construction Sites.
Coordinating And Procuring Materials For Construction Sites.
Documentation Related To Construction Sites (E.g., Defect Reports).
Implementing And Ensuring Compliance With Safety Aspects, E.g. Occupational Safety, Health And Environmental Issues.
Operating Safety Ordinance (Betrsichv) For Pressure Equipment, Qualified Person For Pressure Vessels And Pipelines According To Annex 2, Section 4, No. 3.
Final Testing, Handover To Operator And Acceptance Of Pharmaceutical Equipment.
Liaising With Authorities On Approvals And Deviations As Part Of Optimized Quality Management.
Large-scale Projects Phases 1-9.
Specialization In Gmp Approvals, Especially Qualification And Requalification, Construction Scheduling, Feasibility Studies, And Tenders.
Medical Technology, Expert In Medical Equipment Construction.
Fmea, Plant Engineering, Electrical Engineering, Leadership Experience Across The Entire Value Chain, Specialized Knowledge In Tendering/contract Awarding Under Vol/vob.
Building Services, Site Management, Medical Technology Equipment, And Process Engineering.
Plant Technology, Piping Construction, Compressor Systems Up To 7.0 Purity.
Iso 8573 Et Seq. Compressed Air Systems Up To Class 1.1.1.
Ce Coordination For Medical Devices.
Industrial Project Planning, Public Institutions.
System Audits Including Supplier Audits.
Ensuring Quality Management System Compliance With Standards Such As Iso 13485, Mdd, Mdr, Iso 7396 Et Seq.
Process Audits, Product Audits.
Risk Assessments According To Betrsichv For Pressure-related Hazards.
Plant Engineering Hoai Project Phases 1-9.
Gmp Manufacturing And Engineering.
Iq-fmea.
Executive Management.
Project Management For Large Projects.
Operating Safety Ordinance (Betrsichv), Trbs Etc., Trgs Etc.
Risk Assessment And Analysis According To Iso 14971 Etc. And Iso 31000 Etc.
Hoai, Vob, Vof, Vol.
Construction Process Control.