PROJECT OVERVIEW
Get an overview and learn more about roles and functions in a wide variety of projects.
07/2023 - 10/2023
Active ingredient production |
Bulk filling with insulator
Project Type:
Target:
Role:
Budget:
Project Team:
Revamp, active ingredient production BioTech
Quality assurance, savings
Project engineer/process architect
On request
On request
Complexity: Medium
- Planning a conversion in the area of the bulk filling (isolator and lifting columns)
- Identification of required interfaces
- Estimation of conversion measures through inventory
- Creation of specifications
- Support for 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:
Target:
Role:
Budget:
Project Team:
Quality assurance, medical devices
Compliance with normative requirements
Project Manager
EUR 0.3 million
4 people
Complexity: Medium
- Planning and execution of tests in the area of process development & process design
- Preparation of specifications for system procurement
- Carrying out 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 the implementation of physical product properties
- Qualification & validation of packaging, transport, washing and cleaning processes related to 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:
Target:
Role:
Budget:
Project Team:
Quality assurance, medical devices
Compliance with normative requirements
Project Manager
EUR 0.3 million
4 people
Complexity: Medium
- Planning and execution of tests in the area of process development & process design
- Preparation of specifications for system procurement
- Carrying out 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 the implementation of physical product properties
- Qualification & validation of packaging, transport, washing and cleaning processes related to 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:
Target:
Role:
Budget:
Project Team:
Restructuring, Medical Devices
Standardization, cost saving
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:
Target:
Role:
Budget:
Project Team:
New construction, Medical Devices
Expansion of production, securing of 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 layouts and infrastructure planning
- Support with cost estimation
- Preparation of technical documents (URS)
- Internal and external interface coordination
- Responsible for the management of the qualification clean room & process plants
- Close cooperation with authorities
- Specifications for the validation of the washout processes
- Participation in risk analyses
08/2019 - 08/2021
PRODUCTION TRANSFER | Existing production Line
Project Type:
Target:
Role:
Budget:
Project Team:
Production Transfer & Conversion, Medical Devices
Growth increase, cost savings
Project Manager (Cleanroom & nfrastructure)
On request
On request
Complexity: Medium - High
- Planning of the production transfer
- Comprehensive inventory and process improvement
- Layout planning
- Interface coordination
- Transfer of production processes
- Main contact person for qualification planning process plants & cleanrooms
- Preparation of risk analyses
08/2019 - 11/2020
STANDARDIZATION | Final Cleaning Processes
Project Type:
Target:
Role:
Budget:
Project Team:
Restructuring
Sandardization, cost saving
Project Manager
On request
On request
Complexity: Medium
- Preparation of the central technical specifications (URS)
- Creation and programming of new washing programs
- Roll-out to 3 plants
- Comprehensive test planning
- Validation of the cleaning processes
- Creation of risk analysis
- Project cost estimates as well as time planning
- Interface coordination
02/2019 - 11/2020
REVAMP & STANDARDIZATION | Inventory clean rooms
Project Type:
Target:
Role:
Budget:
Project Team:
Conversion
Compliance with necessary normative requirements
Project engineer, qualification manager
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
- Management qualification planning
- Close consultation with management
- Employee training
10/2019 - 12/2019
PROCESS OPTIMIZATION I Balloon forming process
Project Type:
Target:
Role:
Budget:
Project Team:
Restructuring
Compliance with necessary normative requirements
Project Engineer
On request
On request
Complexity: Medium -High
- Carrying out GAP analyses taking into account international norms & standards
- Detailed process optimization of a molding process
- Roll-out to 8 molding lines
- Comprehensive test planning
- Time & Budget Planning
- Support planning for the optimization of the associated cleanroom processes
- Interface coordination
- Management of qualification & validation
- Close consultation with the production management
- Employee training
12/2015 - 08/2017
NEW CLEANROOM CONSTRUCTIO | OSD Solids production
Project Type:
Target:
Role:
Budget:
Project Team:
New construction, OSD
Production expansion, growth increase
Project Engineer (Cleanroom & Infrastructure)
On request
On request
Complexity: High
> Project flow 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 lock processes and lock equipment as well as interfaces to automation
- Basic coordination to all involved trades (construction & TBE, process, automation)
- Partial responsibility for cleanroom fitting
- Design cost estimates (DCE) of 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 the technical specifications. Specifications for the total clean room expansion
- Supporting plant and 3D planning as well as supporting piping design
- Interface coordination to all involved trades (architecture, TBE / construction etc.)
- Installation of process equipment and GMP-compliant integration in cleanroom construction
- Preparations for the construction of the plant and clean room areas
- Preparations for the qualification of equipment and the clean room
- Support with the detailed planning of the pelletizing plant
08/2015 - 11/2015
PROJECT SUPPORT | OSD Solids Production
Project Type:
Target:
Role:
Budget:
Project Team:
New construction, OSD
Production expansion, growth increase
Project Engineer
On request
On request
Complexity: Low
- Analysis & progress measurements of the project status and progress based on required documents
- Cost and hourly estimates of personnel resources
- Preparation of project documents
08/2015 - 11/2015
REVAMP OF INTERLOCKS | OEB3 Production Area
Project Type:
Target:
Role:
Budget:
Project Team:
Oncology, OSD
Production expansion, growth increase
Supporting project engineer
On request
On request
Complexity: Very high
- Programming the sluice control
- Support in the preparation of drawings and parts lists
- Preparation of GMP-compliant technical documentation
- Project engineer and deputy Project manager on site
- Assistance with metrological planning and installation of walls and ceilings
- Assistance with the assembly of cleanroom ceilings and walls
- On-site interface coordination between. Logistics, QM, Production and Engineering Fa. Baxter
05/2015 - 06/2015
NEW CLEANROOM CONSTRUCTION | GMP AREA | Hospital
Project Type:
Target:
Role:
Budget:
Project Team:
New building, GMP preparation
Production expansion
Supporting project engineer
On request
On request
Complexity: High
- Programming the sluice control
- Support in the preparation of drawings and parts lists
- Preparation of GMP-compliant technical documentation
- Project engineer and deputy Project manager on site
- Assistance with metrological planning and installation of walls and ceilings
- Assistance with the assembly of cleanroom ceilings and walls
- On-site interface coordination between. Logistics, QM, Production and Engineering Fa. Baxter
06/2014 - 08/2014
CLEANROOM SYSTEM CERTIFICATION |
IPA Fraunhofer Stuttgart
Project Type:
Target:
Role:
Budget:
Project Team:
New building, GMP preparation
Production expansion
Working student
n/a
n/a
Complexity: n/a
- System certification in cooperation with IGA Fraunhofer
- Main contact for the evaluation of cleanroom systems according to 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:
Target:
Role:
Budget:
Project Team:
Re-organization, packing
Cost savings
Supporting project engineer
On request
On request
Complexity: Medium
- Statistical preparation of data for the introduction of automated guided vehicles in the GMP production and packaging sector
- Support in the preparation of technical specifications
- Determination of suitable vehicle types (consideration of routes, loads and geometries)
- Definition and specification of fixed docking stations
- Support for the reorganization of the packaging and logistics area
- Support in the creation of a simulation model
- Cooperation in the selection of suppliers
- Support in the comparison of offers
04/2014 - 07/2009
Support planning for GMP production areas
Project Type:
Target:
Role:
Budget:
Project Team:
Conversion
Cost savings, sustainability
Supporting project engineer
n/a
n/a
Complexity: Medium
- Support in various projects, department engineering
- Comprehensive data evaluation and simulation for the introduction of a driverless transport system in final packaging
- Measurement of energy flows to building services and process plants
- Creation of an overall value stream analysis
- Support for the procurement of a pellet plant for the provision of cooling and process energy
- Optimization in the storage of semi-finished goods, support in the reconstruction of storage areas.
- Contact person in specialized topics zw. QM, production and engineering