Dr. Sepp-Georg Bieler
I'm Sepp-Georg Bieler, the founder and driving force behind EnA Bieler Consulting GmbH.
On a personal note, I live in Vienna with my wife. As a proud father and grandfather, I enjoy spending my free time with my family, connecting with friends and former university colleagues, and engaging in activities that help me recharge and maintain a healthy work-life balance.
With a PhD in Chemical Engineering, a professional engineering consultancy license, qualifications as an HSE Coordinator for plant design and construction, and certification as a Project Management Professional (PMP)®, I bring extensive technical expertise and years of experience to complex projects.
I have been working in the life sciences and pharmaceutical industries for over 20 years, with a particular focus on Oral Solid Dosage (OSD), biotechnology, and Fill & Finish operations. Throughout my career, I have successfully managed numerous large-scale TIC projects with multimillion-dollar budgets, from initial concept studies through final acceptance.
My Areas of Expertise:
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Project Management & Coordination
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Stakeholder Management
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Construction Management & Commissioning
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Design & Engineering (Concept Design, Basic Design, Detailed Design)
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Facility Layout & Process Planning
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Qualification (DQ, IQ, OQ, PQ) & Process Validation
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IT Expertise: Software, Hardware & Networking
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Sponsorship & Support of Technical Teams
I combine technical expertise with a structured, solution-oriented approach, providing comprehensive project support with dedication, precision, and a clear focus on what matters most.
Professional experience
January 2024 - today
Dec 2021 - Sept 2023
Sept 2021 - Dec 2021
Feb 2021 - Aug 2021
Dec 2020 - June 2021
Nov 2020 - July 2021
June 2020 - Feb 2021
May 2020 - Aug 2020
March 2020 - June 2020
February 2020 - June 2020
Aug 2019 - Dec 2019
Pharmacy, France (Brownfield, TIC ~ €70 million)
Project management
Construction site coordination
Coordination of commissioning
Coordination of qualification
Biotechnology, Netherlands (brownfield site, TIC ~ €45 million)
Project management
Construction management
Food, Denmark
Commissioning and SAT of a biotechnology plant
Radiopharmacy, Germany
Project management
Adaptation and qualification of the monitoring system
Pharmacy, Germany
Construction management (adaptation of ventilation equipment)
Qualification of air handling systems (including particle measurements)
Veterinary Pharmacy Germany
Project management
(Establishment of a production unit in an area to be adapted)
Veterinary Pharmacy Austria
Project management of the relocation of sampling areas
Preparation of qualification documents
Biotechnology, Austria
Project management for the redesign of the buffer preparation area
(including process modeling and process control)
Pharmaceuticals, Austria
Planning of a building services renovation for packaging areas
Project management for concept
Biotechnology, Netherlands
Preliminary concept for a building renovation for the fermentation area / formulation, filling and finishing area
Preliminary concept for a production building on a greenfield site (warehouse, offices, fermentation area / formulation filling and finishing area)
Biotechnology, Austria
Project management for a brownfield formulation, filling and finishing plant
Concept and basic design
July 2019
Pharmac, Austria
Development of P&IDs for a biotechnology plant
Pharmac, Austria
Development of P&IDs for a biotechnology plant
Aug 2018 - Jan 2019
March 2017 - July 2018
Sept 2016
February 2019 - June 2019
Pharmaceuticals, Germany
Support for creating URSs
Support for laboratory planning
Aug 2016 - Sept 2016
Pharmaceuticals, Switzerland
Design coordinator Bitotech facility (approx. 20,000 m²)
Pharmaceuticals, Austria
Project management (cleanroom, ventilation, black media, electrical, instrumentation and control)
Coordination of qualification, creation of VMP and qualification documents
Coordination of commissioning
Semiconductors, Austria
SHE Audit
Biotechnology, Austria
Creation of URSs for the Compounding System
Dec 2015 - March 2016
Pharma, Sudayr KSA
Project Management Support for a Pharmaceutical Production Facility
Construction site coordination
July 2015 - Nov 2017
Pharmaceuticals, Buraydah KSA
Project management
HSE support
Construction site coordination
Qualification of the clean media and the cleanroom
(including EMS and HVAC systems)Commissioning / SAT of the clean media and the cleanroom
(including EMS and HVAC systems)documentation
Nov 2014 - July 2015
Pharma, St. Petersburg Russia
Construction site monitoring
Commissioning and qualification of the process equipment and purified media for a tablet production plant
Coordination of site completion
(incl. black media, clean media, HVAC, building management systems, process equipment)
March 2014 - Nov 2014
Proposal preparation and concept planning
in the field of pharmaceutical plant design
Sept 2013 - March 2014
Technical management in a pharmaceutical company
Jan 2013 - Aug 2013
Concepts for clients at home and abroad
2010 - 2012
Veterinary Pharmaceuticals, Vienna, Austria
Transfer of packaging facilities
Equipment qualification including document creation
Specifying a new granulation line
Product transfers
Method transfers
Process transfers
2008 - 2009
Pharmaceuticals, Vienna, Austria
Extended Basic Engineering Process and Pure Media
Process design
Relocation and implementation of a used syringe production line into a new production building
Implementation of used equipment in the new process
Building supervision process
Commissioning process
Qualification of plants
2008
Pharmaceuticals, Croatia
Creation of specifications for ultrapure media
2007
Pharmaceuticals, Linz, Austria
Concept study on the adaptation of 2 GMP laboratories
2006
Pharmaceuticals, Linz, Austria
Planning and implementation of adaptations to two pure water systems
2005 - 2008
Biotechnology, Linz, Austria
Concept, basic engineering and implementation of the multi-stage expansion of a blood processing plant
Scale-up of the existing plant
Implementation of existing components into the new process
Building authority
commissioning
2005
Pharmaceuticals, Croatia
Preparation of the tender documents for an ultrapure water plant
2005
Pharmaceutical cleanroom, Austria
Construction supervision for a cleanroom laboratory
2005
Veterinary Pharmaceuticals, Vienna, Austria
Concept, basic and detailed engineering for a pharmaceutical solid dosage form production
2003 - 2004
Biotechnology, Vienna, Austria
Detailed engineering, production monitoring, construction monitoring for the "waste disposal and supply media"
Technical Quality Assurance (FAT) for Containers
Commissioning planning (creation of commissioning manuals, scheduling, process planning, coordination)
Creation of spare parts lists
2003 - 2004
University of Krems, Austria
Concept, basic engineering, detailed engineering of a university laboratory
Building authority
2003
Office building, Eisenstadt, Austria
Project management
2003
Waste processing, Eisenstadt, Austria
Basic Engineering, Tender
2003
Hospital, Vienna, Austria
Preparation of tender documents for the process area of the hospital pharmacy
2002 - 2003
Biotechnology, Linz, Austria
Concept, basic engineering, detailed engineering, construction supervision
2001
Cosmetics, Brazil
Technical support and quotation preparation including planning
2000
TU Wien, Vienna, Austria
Construction of an absorption facility (experimental facility)
2000
Energy, Vienna, Austria
Operation of a membrane separation plant for natural gas on a pilot plant scale (including accompanying analytical measurements)
1998 - 2001
Refinery, Schwechat, Austria
Development of a measurement and control system for DEA scrubbers
1998
Industry, Vienna, Austria
Design and operation of a fluidized bed hot bed model for dry flue gas scrubbing
1997 - 1998
TU Wien, Vienna, Austria
Adaptation and operation of a pilot plant for fluidized bed gasification