Project Management / Quality Management / Industrial Engineering

Process control - medical field
Conformity production according to the Machinery Directive, as well as qualification and validation according to Medical Product Directive of a linked production plant Midsize production company controlled by a Swiss stock corporation.

• Risk assessment of the imported machine
• Stakeholder management for the conversion of the machine
• FMEA according to Medical Devices Act and FDA Chapter H Part 820
• Development of the project structure
• Daily monitoring of the measures
• Participation in meetings and conflict resolution
• Recognize project and business related risks and initiate appropriate actions

Multi-project handling of international and in parallel running projects from level 1 to 4 and aggregation degree 3 (ISA-95 level definition).Midsize production company controlled by a US stock corporation.Single point of contact for ex- & internal customers (Stakeholder management)

• Analysing of contract and URS to support customer in regard of requirement fulfillment
• Development of project structure and formulation and up-date of specialized project plans for quality, time, funds and deliverables
• Writing and follow up on PQP (Project Quality Plan), QAP (Quality Assurance Plan) and the QCP (Quality Control Plan)
• Document management / documentation and reconcile of the documents DQ,IQ, OQ, PQ

Coordination of 10 late scale single plans for the maintenance in the heating and forming area of a aluminium roll plant.
International, stock listed Producer

• Development of project structure and formulation of 24/7 work specialized project plans
• Clearing of collision and overlappings
• Participation in discussions and conflict settlement
• Project plan production in Merlin and MSProject

EU educational project of the federal states of Hamburg and Schleswig-Holstein for foreign engineers by German Federal Labour Market Authority conducted on behalf by IBH (Intercultural education Hamburg registered society)

• Essentials of Project Management

• MSProject 2013 Basics

Multi-project handling of Pharma washer systems for worldwide leading manufacturers of pharmaceutical products

Midsize production company controlled by a Swiss stock corporation.

• Single point of contact for ex- an internal customers (Stakeholder management)
• Analysing of contract and URS to support customer in regard of requirement fulfillment
• Development of project structure and formulation and up-date of specialized project plans for quality, time, funds and deliverables
• Document management / documentation and reconcile of the documents DQ, IQ, OQ, PQ
• Standardisation and matching of missed IQ test protocols within plant and customer
• Claim management: Investigation, assistance, approval and response
• Assure that the claim is managed by the Qualification / Validation and Quality Management system
• Root cause investigation to overcome service or product quality constraint
• Statistic and trend analysis of claim root cause and action taken
• Management of the internal FAT and external SAT
• Assure of safety for customers at FAT and on-site SAT for mechanics
• Realisation regular project and variance report
• Recognise from project-related and business-related risks and initiation of remedy action

Business transformation process to prepare the application of 21 CFR 11 part 11 Electronic Records; Electronic Signatures - Scope and Application

Affiliate production company of a major German stock corporation.

• Analysing of GMP quality requirements and existing business processes run on SAP-ME (MES) for pharmaceutical manufacturer
• Identification of CSF’s (critical success factors) and prearrangement of KSF (Key success factor) metrics
• Root cause investigation for constraint management
• Development of business case for board approval

Analysing of business processes and production flow for the decision making

Medium sized foodstuff producer private limited company 

• Single point of contact for all Stakeholder and management
• Collecting of objectives and preparation requirement management structure
• Development of PSP (project structure plan), OBS (Organisational breakdown structure) and formulation of WBS (work breakdown structure) for all Stakeholders
• Collecting of all pertinent information and data
• Sketch planing of needed inventory in future
• Writing business case for approval of project board on TOC base

EU educational project of the federal states of Hamburg and Schleswig-Holstein for foreign engineers by German Federal Labour Market Authority conducted on behalf by IBH (Intercultural education Hamburg registered society)

• Essentials of Project Management

• MSProject 2013 Basics

Preliminary examination and licensing for production of a special vehicle in the underground dump area for weak-radioactive and medium radioactive wast (shaft arrangement Konrad).

Consortium of midsize manufacturing company controlled by major German stock corporation and affiliate engineering office of major German technical supervisory association and representative of the Federal Office for radiation protection (BfS).

• Central contact point for information and documentation handling
• Analysing of governmental „plan approval order“ for the high lining of requirements to fulfill
• Development of PSP (project structure plan) and formulation and follow-up on WBS (work breakdown structure) for the consortium
• Document management / documentation and reconcile of the qualification documents
• Standardisation and matching of missed test protocols for equipment underground validation
• Realisation regular project and variance report
• Recognise from project-related and business-related risks and initiation of remedy action
• Work with the responsible consortium member and second level supplier

Preliminary examination and licensing for production of a special vehicle in the underground dump area for weak-radioactive and medium radioactive wast (shaft arrangement Konrad).
Consortium of midsize manufacturing company controlled by major German stock corporation and affiliate engineering office of major German technical supervisory association and representative of the Federal Office for radiation protection (BfS).

• Central contact point for information and documentation handling
• Analysing of governmental „plan approval order“ for the high lining of requirements to fulfill
• Development of PSP (project structure plan) and formulation and follow-up on WBS (work breakdown structure) for the consortium
• Writing and follow up on PQP (Project Quality Plan), QAP (Quality Assurance Plan) and the QCP • Standardisation and matching of missed test protocols for equipment underground validation
• Realisation regular project and variance report
• Recognise from project-related and business-related risks and initiation of remedy action
• Work with the responsible consortium member and second level supplier

EU educational project of the federal states of Hamburg and Schleswig-Holstein for foreign engineers by German Federal Labour Market Authority conducted on behalf by IBH (Intercultural education Hamburg registered society)

• Essentials of Project Management

• MSProject 2013 Basics

EU educational project of the federal states of Hamburg and Schleswig-Holstein for foreign engineers by German Federal Labour Market Authority conducted on behalf by IBH (Intercultural education Hamburg registered society)

• Essentials of Project Management

• MSProject 2013 Basics

Analysing of business processes and production flow for the decision making Medium sized foodstuff producer private limited company

• Single point of contact for all Stakeholder and management
• Collecting of objectives and preparation requirement management structure
• Development of PSP (project structure plan), OBS (Organisational breakdownstructure) and formulation of WBS (work breakdown structure) for allStakeholders
• Collecting of all pertinent information and data
• Sketch planing of needed inventory in future
• Writing business case for approval of project board on TOC base

Training mandates
EU educational project of the federal states of Hamburg and Schleswig-Holstein for foreign engineers by German Federal Labour Market Authority conducted on behalf by IBH (Intercultural education Hamburg registered society)

Multi-project handling of systems (no further description)

German engineering office of a major US stock corporation

• Single point of contact for external customers (Stakeholder management)
• Analysing of contract and URS to support customer in regard of requirement fulfillment
• Development of project structure and formulation of WBS (work breakdown structure) for the project
• Quality management of subcontractor
• Document management of quality proof certificates
• Claim management: Investigation, assistance, approval and response
• Claim brought into global Quality Management system, follow up of responses
• Root cause investigation to overcome service or product quality constraint
• Reconcile of the internal and external FAT and SAT
• Assure of safety for customers at FAT and on-site SAT for mechanics
• Realisation regular project and variance report
• Recognise from project-related and business-related risks and initiation of remedy action

EU educational project of the federal states of Hamburg and Schleswig-Holstein for foreign engineers by German Federal Labour Market Authority conducted on behalf by IBH (Intercultural education Hamburg registered society)

• Essentials of Project Management

• MSProject 2013 Basics

Analysing of business processes and production flow for decision making

Small sized production for stainless stell elements and pre-assembled components private limited company

• Single point of contact for all Stakeholder and management
• Collecting of objectives and preparation requirement management structure
• Alignment of objectives as moderater
• Development of PSP (project structure plan), OBS (Organisational breakdown structure) and formulation of WBS (work breakdown structure) for all Stakeholders
• Collecting of all pertinent information and data
• Writing business case for approval of project board

Re-engineering of business processes and production flow

Small sized production company for pre-assembled components private limited company

• Increase of lean management competence
• Conducting of time-and-motion studies
• Sketch planning of production and manufacturing flow by having the focus of the conditions of work and an optimised surface and space exploitation as well as a high flexibility of the constructions, arrangements and facilities.
• Calculation of profitability

Technology assessment gassing versus irradiation of animal feed

Negotiations with Health Canada

Lay out planning , Costing to HOAI

PMO management within the European matrix organisation for the supply of service and project engineering for 11 works

Factory planning - strategical and surgical project management for new buildings and rebuildings,

Planning, calculation, assessment and realisation to HOAI

Planning of production and manufacturing flow

Backup of the conditions of work and an optimised surface and space exploitation as well as a high flexibility of the constructions, arrangements and facilities.

Introduction of Lean management

Personnel responsibility for 4 hired engineers and up to 20 project employees