PROJECT OVERVIEW
Get an overview and learn more about roles and functions in a wide variety of projects.
01/2026 - 05/2026
ACTIVE INGREDIENT PRODUCTION |
Conversion/new construction of existing buildings
Project type:
Goal:
Role:
Budget:
Project team:
Conversion, active ingredient production BioTech
Quality assurance, savings
Construction Manager
On request
On request
Complexity: Medium
- Review and approval of factory and assembly drawings for the construction
of the laboratory and production area
- Coordination of the construction of the clean room in the laboratory (Drug Substances) and production area (DP Area)
- Coordination of the construction of the laboratory area (laboratory furniture and general airlock equipment) - Management on site/regular participation in construction meetings - Coordination of the construction of the cold room - Coordination of interfaces between all trades involved (architecture, TGA, process) - Management of the construction site/regular participation in construction meetings Laboratory area equipment (laboratory furniture and general airlock equipment)
- Management on the construction site/regular participation in construction meetings
- Coordination of cold room expansion
- Interface coordination between all trades involved (architecture, TGA, process)
- Deputy construction management overall
- Construction management and participation in regular construction meetings
06/2025 - 12/2025
ACTIVE INGREDIENT PRODUCTION |
Conversion/new construction of existing buildings
Project type:
Goal:
Role:
Budget:
Project team:
Conversion, active ingredient production BioTech
Quality assurance, savings
Construction Manager
On request
On request
Complexity: Medium
- Review and approval of factory and assembly drawings for the construction
of the laboratory and production area
- Coordination of the construction of the clean room in the laboratory (Drug Substances) and production area (DP Area)
- Coordination of the construction of the laboratory area (laboratory furniture and general airlock equipment) - Management on site/regular participation in construction meetings - Coordination of the construction of the cold room - Coordination of interfaces between all trades involved (architecture, TGA, process) - Management of the construction site/regular participation in construction meetings Laboratory area equipment (laboratory furniture and general airlock equipment)
- Management on the construction site/regular participation in construction meetings
- Coordination of cold room expansion
- Interface coordination between all trades involved (architecture, TGA, process)
- Deputy construction management overall
- Construction management and participation in regular construction meetings
11/2024 - 05/2025
ACTIVE INGREDIENT PRODUCTION |
Conversion/new construction of existing buildings
Project type:
Goal:
Role:
Budget:
Project team:
Conversion, active ingredient production BioTech
Quality assurance, savings
Project engineer/process architect
On request
On request
Complexity: Medium
- Recording user requirements for the construction of new cleanroom areas in the existing building
- Detailed planning of airlocks and cleanroom modifications in the DD phase
- Detailed planning of the entire laboratory area (Cell Lab, Purifcation, Molecular Lab)
- Preparation of tender documents (cleanroom, laboratory area and airlock facilities)
- Support with 3D collision planning and layout development
- Detailed planning of ancillary areas (e.g. cold storage and technical areas) - Support with ventilation planning (preparation of room books, recording of as-built plans) - Interface coordination with EHS, building automation and other tradese.g. cold storage, technical areas)
- Support with ventilation planning (creation of room books, recording of as-built plans)
- Interface coordination with EHS, building automation and other trades
01/2024 - 12/2024
PROCESS OPTIMIZATION |
Implementation of regulatory requirements
Project type:
Goal:
Role:
Budget:
Project team:
Quality assurance, medical devices
Compliance with normative requirements
Project manager
On request
4 people
Complexity: Medium
- Planning and execution of tests in the area of process development & process design
- Creation of specifications for equipment procurement
- Execution of risk analyses (FMEA)
- Creation, updating and training of process, test and work instructions
- Execution and documentation of required validations / re-validations of processes & software - Planning of physical product properties - Qualification & validation of packaging, transport, washing and cleaning processes in connection with products - Qualification & validation of cleanrooms (FMEA) Software
- Planning the implementation of physical product properties
- Qualification & validation of packaging, transport, washing and cleaning processes in connection with products
- Qualification and validation of cleanrooms (ISO class 7/8 according to DIN EN 14644)
- Preparations for internal and external audits
07/2023 - 10/2023
ACTIVE INGRIDIENT PRODUCTION |
Bulk filling conversion with insulator
Project type:
Goal:
Role:
Budget:
Project team:
Conversion, active ingredient production BioTech
Quality assurance, savings
Project engineer/process architect
On request
On request
Complexity: Medium
- Planning of a conversion in the area of bulk filling (isolator and lifting columns)
- Identification of required interfaces
- Estimation of conversion measures by inventory
- Creation of specifications
- Support in 3D collision planning
- Creation of a dismantling concept
- Technical support for the re-qualification of the cleanroom
01/2023 - 12/2023
PROCESS OPTIMIZATION |
Implementation of regulatory requirements
Project type:
Goal:
Role:
Budget:
Project team:
Quality assurance, medical devices
Compliance with normative requirements
Project manager
On request
4 people
Complexity: Medium
- Planning and execution of tests in the area of process development & process design
- Creation of specifications for equipment procurement
- Execution of risk analyses (FMEA)
- Creation, updating and training of process, test and work instructions
- Execution and documentation of required validations / re-validations of processes & software - Planning of physical product properties - Qualification & validation of packaging, transport, washing and cleaning processes in connection with products - Qualification & validation of cleanrooms (FMEA) Software
- Planning the implementation of physical product properties
- Qualification & validation of packaging, transport, washing and cleaning processes in connection with products
- Qualification and validation of cleanrooms (ISO class 7/8 according to DIN EN 14644)
- Preparations for internal and external audits
06/2022 - 12/2022
PROCESS OPTIMIZATION |
Implementation of regulatory requirements
Project type:
Goal:
Role:
Budget:
Project team:
Quality assurance, medical devices
Compliance with normative requirements
Project manager
On request
4 people
Complexity: Medium
- Planning and execution of tests in the area of process development & process design
- Creation of specifications for equipment procurement
- Execution of risk analyses (FMEA)
- Creation, updating and training of process, test and work instructions
- Execution and documentation of required validations / re-validations of processes & software - Planning of physical product properties - Qualification & validation of packaging, transport, washing and cleaning processes in connection with products - Qualification & validation of cleanrooms (FMEA) Software
- Planning the implementation of physical product properties
- Qualification & validation of packaging, transport, washing and cleaning processes in connection with products
- Qualification and validation of cleanrooms (ISO class 7/8 according to DIN EN 14644)
- Preparations for internal and external audits
03/2019 - 02/2022
GLOBAL STANDARDIZATION | Hardening Processes
Project type:
Goal:
Role:
Budget:
Project team:
Restructuring, medical devices
Standardization, cost savings
Project engineer, quality engineer
On request
On request
Complexity: Medium
- Standardization of the hardening process
- Comprehensive test planning
- Definition of the new hardening process & rollout
- Presentation of the project status
- Contact person for process validation
- Process optimization
09/2019 - 02/2021
NEW CLEANROOM CONSTRUCTION | Complete planing
Project type:
Goal:
Role:
Budget:
Project team:
New building, medical devices
Production expansion, securing location
Project manager
On request
On request
Complexity: Very high
- Project management from project start, design planning, detailed planning, construction supervision, acceptance & qualification
- Specifications for layout and infrastructure planning
- Cost estimation support
- Preparation of technical documents (URS)
- Internal and external interface coordination
- Responsible for managing the qualification of cleanroom & process equipment
- Close cooperation with authorities
- Specifications for the validation of washout processes
- Participation in risk analyses
08/2019 - 08/2021
PRODUCTION TRANSFER | Existing production Line
Project type:
Goal:
Role:
Budget:
Project team:
Production transfer & conversion, medical devices
Growth increase, cost savings
Project manager (clean room & infrastructure)
On request
On request
Complexity: Medium - High
- Production transfer planning
- Comprehensive inventory and process improvement
- Layout planning
- Interface coordination
- Transfer of production processes
- Main contact for qualification planning Process plants & clean rooms
- Preparation of risk analyses
08/2019 - 11/2020
STANDARDIZATION | Final Cleaning Processes
Project type:
Goal:
Role:
Budget:
Project team:
Restructuring
Sandardization, cost savings
Project manager
On request
On request
Complexity: Medium
- Creation of the central technical specifications (URS)
- Creation and programming of new washing programs
- Roll-out on 3 systems
- Comprehensive test planning
- Validation of the cleaning process
- Creation of the risk analysis
- Project cost estimates and scheduling
- Interface coordination
02/2019 - 11/2020
REVAMP & STANDARDIZATION | Inventory clean rooms
Project type:
Goal:
Role:
Budget:
Project team:
Conversion
Compliance with necessary normative requirements
Project engineer, head of qualification
On request
On request
Complexity: Medium
- Carrying out a GAP analysis taking into account international norms & standards
- Layout planning for the introduction of a uniform lock concept
- Interface coordination
- Head of qualification planning
- Close consultation with management
- Training of employees
10/2019 - 12/2019
PROCESS OPTIMIZATION I Balloon forming process
Project type:
Goal:
Role:
Budget:
Project team:
Re-structuring
Compliance with necessary normative requirements
Project engineer
On request
On request
Complexity: Medium -High
- Implementation of GAP analyses taking into account international norms & standards
- Detailed process optimization of a molding process
- Roll-out on 8 molding systems
- Comprehensive test planning
- Time & budget planning
- Supporting planning in the optimization of the associated cleanroom processes
- Interface coordination
- Management of qualification & validation measures
- Close consultation with production management
- Training of employees
12/2015 - 08/2017
NEW CLEANROOM CONSTRUCTIO | OSD Solids production
Project type:
Goal:
Role:
Budget:
Project team:
New building, OSD
Production expansion, growth increase
Project engineer (clean room & infrastructure)
On request
On request
Complexity: High
> Basic Design Phase <
- Planning of material and personnel flows as well as zone layout
- Supporting planning for the infrastructure of process equipment and cleanroom monitoring
- Planning of airlock processes and airlock equipment as well as interfaces to automation
- Basic coordination with all trades involved (construction & TGA, process, automation)
- Partial responsibility for cleanroom fit-out
- Design cost estimates (DCE) for the entire cleanroom area
- Value engineering and cost savings
> Project flow detail design phase <
- Responsibility for logistical material and personnel flows, adaptation of zone layout
- Overall responsibility for cleanroom fit-out
- Preparation of the bill of quantities and technical specifications for the overall cleanroom fit-out
- Supporting plant and 3D planning as well as supporting piping planning
- Interface coordination with all trades involved (architecture, TGA / construction etc.) - Preparation of process equipment and GMP integration in cleanroom construction - Preparations for the construction of plant and cleanroom areas - Preparations for the qualification of equipment and cleanroom areas
- Installation of process equipment and GMP-compliant integration in the cleanroom construction
- Preparations for the construction of the plant and cleanroom areas
- Preparations for the qualification of equipment and the cleanroom
- Support in the detailed planning of the granulation plant
08/2015 - 11/2015
PROJECT SUPPORT | OSD Solids Production
Project type:
Goal:
Role:
Budget:
Project team:
New building, OSD
Production expansion, growth increase
Project engineer
On request
On request
Complexity: Low
- Analysis and progress measurements of the project status and progress based on required documents
- Cost and hourly estimates of human resources
- Preparation of project documents
08/2015 - 11/2015
REVAMP OF INTERLOCKS | OEB3 Production Area
Project type:
Goal:
Role:
Budget:
Project team:
Oncology, OSD
Production expansion, growth increase
Supporting project engineer
On request
On request
Complexity: Very high
- Programming of the airlock control system
- Support in the creation of drawings and parts lists
- Creation of GMP-compliant technical documentation
- Project engineer and deputy project manager on site
- Support in the metrological planning and installation of the walls and ceilings
- Assistance in the installation of the cleanroom ceilings and walls
- On-site interface coordination between the cleanroom and the cleanroom management Logistics, QM, Production and Engineering Fa. Baxter
05/2015 - 06/2015
NEW CLEANROOM CONSTRUCTION | GMP AREA | Hospital
Project type:
Goal:
Role:
Budget:
Project team:
New construction, GMP processing
Production expansion
Supporting project engineer
On request
On request
Complexity: High
- Programming of the airlock control system
- Support in the creation of drawings and parts lists
- Creation of GMP-compliant technical documentation
- Project engineer and deputy project manager on site
- Support in the metrological planning and installation of the walls and ceilings
- Assistance in the installation of the cleanroom ceilings and walls
- On-site interface coordination between the cleanroom and the cleanroom management Logistics, QM, Production and Engineering Fa. Baxter
06/2014 - 08/2014
CLEAN CLEANING SYSTEM CERTIFICATION |
IPA Fraunhofer Stuttgart
Project type:
Goal:
Role:
Budget:
Project team:
New building, GMP preparation
Production expansion
Working student
n/a
n/a
Complexity: n/a
- System certification in cooperation with the IGA Fraunhofer
- Main contact person for the evaluation of cleanroom systems in accordance with ISO EN 14644, VDI2083
- Support in the preparation of the overall report
04/2014 - 07/2009
INTRODUCTION OF A DRIVERLESS TRANSPORT SYSTEM | GMP OSD Production Area
Project type:
Goal:
Role:
Budget:
Project team:
Re-organization, packaging
Cost savings
Supporting project engineer
On request
On request
Complexity: Medium
- Statistical preparation of data for the introduction of driverless transport systems in the GMP production and packaging area
- Support in the preparation of the technical specifications
- Determination of suitable vehicle types (consideration of routes, loads and geometries)
- Definition and specification of fixed docking stations
- Support in the conversion of the packaging and logistics area
- Support in the creation of a simulation model
- Collaboration in the selection of suppliers
- Support in the comparison of offers
04/2014 - 07/2009
Support planning for GMP production areas
Project type:
Goal:
Role:
Budget:
Project team:
Conversion
Cost savings, sustainability
Supporting project engineer
n/a
n/a
Complexity: Medium
- Support for various projects in the Engineering department
- Comprehensive data evaluation and simulation for the introduction of a driverless transport system in final packaging
- Measurement-based recording of energy flows for building services and process plants
- Creation of a comprehensive value stream analysis
- Support in the procurement of a pellet plant for the provision of cooling and process energy
- Optimization of the storage of semi-finished goods, support in the conversion of storage areas
- Contact person for technical issues between QM, production and engineering