project management, pharmaceutical process technology, sterile and biotechnology, design, qualification, process validation, maintenance excellence
Aktualisiert am 28.05.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 28.05.2024
Verfügbar zu: 100%
davon vor Ort: 80%
Project Management
Adaptability and Flexibility
in-depth pharma industry Knowledge
Regulatory Compliance
Quality Management
Analytical and Problem-Solving Abilities
Communication and Interpersonal Skills
Business Acumen
Continuous Learning
Ethical Conduct
German
English
Spanish
Portuguese

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2023 - 2024: Upgrade pharmaceutical production facilities


Customer: AENOVA GROUP, Germany


Tasks:

  • Conceptual and Detail Engineering of process equipment and HVAC
  • coordination of suppliers and installation coordination

2023 - 2024: Maintenance & SAP implementation


Customer: Wacker Biotech - Germany


Tasks:

  • Implementation of a risk-based maintenance program and reorganization of maintenance department
  • Implementation of maintenance software (SAP PM)

2022 - 2024: Upgrade pharmaceutical production facilities


Customer: MSD, Austria


Tasks:

  • Conceptual and Detail Engineering, coordination of suppliers and installation coordination of granulation suite
  • Qualification of equipment and support by process validation


2021 - 2023: New vaccines production facility


Customer: RECIPHARM, MARBIO Morocco


Tasks:

  • Detail Engineering, coordination of Chinese suppliers and coordination of installation at site of 3 sterile filling lines for biological products and Moderna vaccine

2020 ? 2023: New production facility for blood plasma products


Customer: LIFEFACTORS Medellin Colombia


Tasks:

  • Conceptual, basic and detail engineering of the new plant for blood plasma fractionation based on a patented process and production of 2 blood plasma products


2020 ? 2022: Due-diligence studies and reengineering projects


Customer: Ensignadvisory GmbH


Tasks:

  • Support by the preparation and execution of due diligence studies and reengineering projects of manufacturers of process and packaging equipment


2019 - 2022: Engineering & Maintenance


Customer: FERRING GmbH, Germany


Tasks:

  • Implementation of a maintenance program and reorganization of maintenance department
  • Implementation of maintenance software (oracle) and preparation of SAP migration
  • Planning and support for yearly maintenance shutdowns

2020 - 2021: Production expansion of the pharmaceutical production facility


Customer: AENOVA GROUP, Germany


Tasks:

  • Project management, Engineering and specification of equipment
  • Procurement and installation coordination of facility for the production of tablets and capsules

2019 ? 2020: New production facility for blood plasmaproducts


Customer: OCTAPHARMA Moscow - Russia


Tasks:

  • Conceptual and basic engineering of the plant for blood plasma fractionation and the production of 10 blood plasma products on behalf of Glatt Engineering


2019 ? 2020: New production facility for vaccines


Customer: BIOPHARMA Indonesia


Tasks:

  • Conceptual and basic engineering of the new vaccines facility on behalf of Airplan Spain


2017 ? 2018: New production facility for blood plasma products


Customer: BIOTEST Dreieich, Germany


Tasks:

  • Conceptual engineering of the plant for blood plasma fractionation and the production of 2 blood plasma products


2016 ? 2017: New production facility for blood plasma products


Customer: GREEN CROSS Montreal, Canada


Tasks:

  • Conceptual engineering of the plant for blood plasma fractionation


Production expansion


Customer: JOHNSON&JOHNSON Madrid - Spain


Tasks:

  • Project management
  • Engineering and specification of equipment
  • Procurement and installation coordination of two packaging lines


New production facility for high potent products


Customer: NOVARTIS Stein - Switzerland


Tasks:

  • Project management
  • Engineering and specification of equipment
  • Procurement and installation coordination of 4 production lines (OEB4/5)


New production facility for vaccines


Customer: JOHNSON&JOHNSON - CRUCELL Leiden - Netherlands


Tasks:

  • Detail Engineering and Installation coordination of the facility for the vaccines production


---older projects on Request---

Aus- und Weiterbildung

Aus- und Weiterbildung

1993 - 1996

Technical University of Dresden (TU Dresden)

  • PhD Engineer (Doktoringenieur-Dr.-Ing.)
  • Specialization: thermos-fluid dynamics, power plants & turbines
  • Doctoral thesis: Experimental study of heat transport processes in an effusion plate (turbine combustion chamber)


1988 - 1993

Technical University of Dresden (TU Dresden)

  • Master Engineer (Diplomingenieur-Dipl.-Ing.)
  • Degree program: mechanical engineering
  • Specialization: power generation engineering


CERTIFICATIONS / TRAININGS:

  • Project Management Degree (RKW / GPM)
  • Lean Six Sigma training by Bosch
  • Diverse pharmaceutical Trainings by PTS, Concept Heidelberg, ISPE, Bosch, Glatt and pharmaceutical companies
  • Leadership Management training by LMI in Waco USA

Kompetenzen

Kompetenzen

Top-Skills

Project Management Adaptability and Flexibility in-depth pharma industry Knowledge Regulatory Compliance Quality Management Analytical and Problem-Solving Abilities Communication and Interpersonal Skills Business Acumen Continuous Learning Ethical Conduct

Produkte / Standards / Erfahrungen / Methoden

PROFILE:

The freelancer is a mechanical engineer with a master's degree in process and power plant engineering and a doctorate in thermo-fluid dynamics and has more than 25 years of experience in the pharmaceutical and biotechnology industries executing international projects for well-known process equipment suppliers as well as pharmaceutical manufacturers and consulting firms. Areas of focus: Pharmaceutical process technology, technology transfer, maintenance excellence and project management.


PROFESSIONAL EXPERIENCE:

2019 ? today

Role: Managing director & Consultant

Customer: Cotectra GmbH, Radebeul, Germany


Tasks:

  • Consulting, engineering and project management in the execution of pharmaceutical, sterile, containment and biotechnology projects worldwide
  • Equipment Procurement (expediting) and supplier auditing and monitoring
  • Technical expertise by execution of reengineering and maintenance projects and by implementation of CMMS


2014 ? 2019

Role: Business and Project development Director

Customer: Pharmatec GmbH, a Bosch company, Dresden, Germany


Tasks:

  • Business Development for biotechnological and sterile process equipment
  • Tender management and Project development during the bidding phase
  • Project management of projects >5 million Euro during the initialization phase
  • Member of the management board and member of reengineering team of management and production processes (Lean Six Sigma) according to Bosch standards


2009 ? 2014

Role: Managing director & Consultant

Customer: International Quality Engineering GmbH, Reinheim, Germany


Tasks:

  • Consulting, engineering and project management in the execution of pharmaceutical and biotechnological projects worldwide
  • Equipment Procurement (expediting) and supplier auditing and monitoring
  • Equipment qualification and process validation and computer validation of MES systems


2005 ? 2009

Role: Director of service department

Customer: Pharmatec GmbH, a Bosch company, Dresden, Germany


Tasks:

  • Planning and coordination of the service and installation activities worldwide
  • Planning & coordination of large shutdowns
  • Project management and installation coordination for large projects > 2 million Euro
  • Member of the board and project management in the implementation of processes and methodologies according to Bosch standards


1999 ? 2005

Role: Technical support and Project Manager

Customer: Glatt Systemtechnik GmbH, Dresden, Germany


Tasks:

  • Project development and project management for pharmaceutical granulation lines worldwide
  • Product manager for granulation and drying processes and development of new equipment


1998 ? 1999

Role: Installation manager

Customer: Dürr, Germany / Vizdürr, Spain


Tasks:

  • Installation management of drying systems and production lines in the painting plant of Audi/VW in Curitiba Brazil


1996 - 1998

Role: Process Development engineer and Project manager

Customer: Industrieservice GmbH, Bruckmühl, Germany


Tasks:

  • Project management and process development engineer of infrared systems for industrial applications like painting processes, paper, plastic & robber treatment

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2023 - 2024: Upgrade pharmaceutical production facilities


Customer: AENOVA GROUP, Germany


Tasks:

  • Conceptual and Detail Engineering of process equipment and HVAC
  • coordination of suppliers and installation coordination

2023 - 2024: Maintenance & SAP implementation


Customer: Wacker Biotech - Germany


Tasks:

  • Implementation of a risk-based maintenance program and reorganization of maintenance department
  • Implementation of maintenance software (SAP PM)

2022 - 2024: Upgrade pharmaceutical production facilities


Customer: MSD, Austria


Tasks:

  • Conceptual and Detail Engineering, coordination of suppliers and installation coordination of granulation suite
  • Qualification of equipment and support by process validation


2021 - 2023: New vaccines production facility


Customer: RECIPHARM, MARBIO Morocco


Tasks:

  • Detail Engineering, coordination of Chinese suppliers and coordination of installation at site of 3 sterile filling lines for biological products and Moderna vaccine

2020 ? 2023: New production facility for blood plasma products


Customer: LIFEFACTORS Medellin Colombia


Tasks:

  • Conceptual, basic and detail engineering of the new plant for blood plasma fractionation based on a patented process and production of 2 blood plasma products


2020 ? 2022: Due-diligence studies and reengineering projects


Customer: Ensignadvisory GmbH


Tasks:

  • Support by the preparation and execution of due diligence studies and reengineering projects of manufacturers of process and packaging equipment


2019 - 2022: Engineering & Maintenance


Customer: FERRING GmbH, Germany


Tasks:

  • Implementation of a maintenance program and reorganization of maintenance department
  • Implementation of maintenance software (oracle) and preparation of SAP migration
  • Planning and support for yearly maintenance shutdowns

2020 - 2021: Production expansion of the pharmaceutical production facility


Customer: AENOVA GROUP, Germany


Tasks:

  • Project management, Engineering and specification of equipment
  • Procurement and installation coordination of facility for the production of tablets and capsules

2019 ? 2020: New production facility for blood plasmaproducts


Customer: OCTAPHARMA Moscow - Russia


Tasks:

  • Conceptual and basic engineering of the plant for blood plasma fractionation and the production of 10 blood plasma products on behalf of Glatt Engineering


2019 ? 2020: New production facility for vaccines


Customer: BIOPHARMA Indonesia


Tasks:

  • Conceptual and basic engineering of the new vaccines facility on behalf of Airplan Spain


2017 ? 2018: New production facility for blood plasma products


Customer: BIOTEST Dreieich, Germany


Tasks:

  • Conceptual engineering of the plant for blood plasma fractionation and the production of 2 blood plasma products


2016 ? 2017: New production facility for blood plasma products


Customer: GREEN CROSS Montreal, Canada


Tasks:

  • Conceptual engineering of the plant for blood plasma fractionation


Production expansion


Customer: JOHNSON&JOHNSON Madrid - Spain


Tasks:

  • Project management
  • Engineering and specification of equipment
  • Procurement and installation coordination of two packaging lines


New production facility for high potent products


Customer: NOVARTIS Stein - Switzerland


Tasks:

  • Project management
  • Engineering and specification of equipment
  • Procurement and installation coordination of 4 production lines (OEB4/5)


New production facility for vaccines


Customer: JOHNSON&JOHNSON - CRUCELL Leiden - Netherlands


Tasks:

  • Detail Engineering and Installation coordination of the facility for the vaccines production


---older projects on Request---

Aus- und Weiterbildung

Aus- und Weiterbildung

1993 - 1996

Technical University of Dresden (TU Dresden)

  • PhD Engineer (Doktoringenieur-Dr.-Ing.)
  • Specialization: thermos-fluid dynamics, power plants & turbines
  • Doctoral thesis: Experimental study of heat transport processes in an effusion plate (turbine combustion chamber)


1988 - 1993

Technical University of Dresden (TU Dresden)

  • Master Engineer (Diplomingenieur-Dipl.-Ing.)
  • Degree program: mechanical engineering
  • Specialization: power generation engineering


CERTIFICATIONS / TRAININGS:

  • Project Management Degree (RKW / GPM)
  • Lean Six Sigma training by Bosch
  • Diverse pharmaceutical Trainings by PTS, Concept Heidelberg, ISPE, Bosch, Glatt and pharmaceutical companies
  • Leadership Management training by LMI in Waco USA

Kompetenzen

Kompetenzen

Top-Skills

Project Management Adaptability and Flexibility in-depth pharma industry Knowledge Regulatory Compliance Quality Management Analytical and Problem-Solving Abilities Communication and Interpersonal Skills Business Acumen Continuous Learning Ethical Conduct

Produkte / Standards / Erfahrungen / Methoden

PROFILE:

The freelancer is a mechanical engineer with a master's degree in process and power plant engineering and a doctorate in thermo-fluid dynamics and has more than 25 years of experience in the pharmaceutical and biotechnology industries executing international projects for well-known process equipment suppliers as well as pharmaceutical manufacturers and consulting firms. Areas of focus: Pharmaceutical process technology, technology transfer, maintenance excellence and project management.


PROFESSIONAL EXPERIENCE:

2019 ? today

Role: Managing director & Consultant

Customer: Cotectra GmbH, Radebeul, Germany


Tasks:

  • Consulting, engineering and project management in the execution of pharmaceutical, sterile, containment and biotechnology projects worldwide
  • Equipment Procurement (expediting) and supplier auditing and monitoring
  • Technical expertise by execution of reengineering and maintenance projects and by implementation of CMMS


2014 ? 2019

Role: Business and Project development Director

Customer: Pharmatec GmbH, a Bosch company, Dresden, Germany


Tasks:

  • Business Development for biotechnological and sterile process equipment
  • Tender management and Project development during the bidding phase
  • Project management of projects >5 million Euro during the initialization phase
  • Member of the management board and member of reengineering team of management and production processes (Lean Six Sigma) according to Bosch standards


2009 ? 2014

Role: Managing director & Consultant

Customer: International Quality Engineering GmbH, Reinheim, Germany


Tasks:

  • Consulting, engineering and project management in the execution of pharmaceutical and biotechnological projects worldwide
  • Equipment Procurement (expediting) and supplier auditing and monitoring
  • Equipment qualification and process validation and computer validation of MES systems


2005 ? 2009

Role: Director of service department

Customer: Pharmatec GmbH, a Bosch company, Dresden, Germany


Tasks:

  • Planning and coordination of the service and installation activities worldwide
  • Planning & coordination of large shutdowns
  • Project management and installation coordination for large projects > 2 million Euro
  • Member of the board and project management in the implementation of processes and methodologies according to Bosch standards


1999 ? 2005

Role: Technical support and Project Manager

Customer: Glatt Systemtechnik GmbH, Dresden, Germany


Tasks:

  • Project development and project management for pharmaceutical granulation lines worldwide
  • Product manager for granulation and drying processes and development of new equipment


1998 ? 1999

Role: Installation manager

Customer: Dürr, Germany / Vizdürr, Spain


Tasks:

  • Installation management of drying systems and production lines in the painting plant of Audi/VW in Curitiba Brazil


1996 - 1998

Role: Process Development engineer and Project manager

Customer: Industrieservice GmbH, Bruckmühl, Germany


Tasks:

  • Project management and process development engineer of infrared systems for industrial applications like painting processes, paper, plastic & robber treatment

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