Expertise and career
Thomas Makait
Dipl.-Ing. (FH), Managing DirectorI would be happy to support you, your employees and your organization in professionally managing complexity, mastering crises, exploiting opportunities, mastering risks and efficiently achieving goals!
Please feel free to contact me!
Professional Focus
– Systemic organizational consulting / consulting in the “third mode”
Thomas Makait supports companies in the chemical and pharmaceutical process industry as well as in international (large-scale) plant construction in developing established quality, project, risk and information security management into high-performance and high-reliability organizations (HRO).
As a project-accompanying sparring partner for large and mega projects, Thomas supports project organizations in managing complexity professionally. He uses the “Project Vital Analysis® – Transparency for Project Efficiency” method, which he developed himself. This method has already proven its worth in over 85 projects with a project duration of over 250 years and a contract value of more than EUR 15 billion.
=> more than 5 years of practical experience
– Validation strategies for complex computerized system networks, achieving and maintaining data integrity Data governance
e.g. from store floor to SAP: PLC / PI <=> SCADA / DCS <=> (LIMS / BDIS / EBRS) <=> ERP,
Assessment and further development of engineering organizations, suppliers and service providers in the pharmaceutical industry
=> more than 19 years of practical experience in responsible positions
– Introduction of risk, quality and information security management systems
(ISO 31000, ONR 49000, ISO 9001, ISO 27001, ICH Q7 / EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines / Annex 11, 21 CFR 210 / 21 CFR 211, 21 CFR 11, GAMP®5)
=> more than 15 years of practical experience in responsible positions
– Consulting in the areas of strategic and operational project risk management, dynamic project risk controlling
=> more than 5 years of practical experience in responsible positions
– Audit of operational project risk management, dynamic project risk controlling and result forecasting in international large-scale plant construction
=> more than 19 years of practical experience in responsible positions
– Audit of quality, project, risk and information security management systems
=> more than 13 years of practical experience in responsible positions
Key areas of expertise
– Supporting companies in the chemical and pharmaceutical process industry as well as international (large-scale) plant construction in developing established quality, project, risk and information security management into high-performance and high-reliability organizations
– Leading engineering, validation, qualification, migration and efficiency improvement projects in a national and international environment
– Introduction of quality, risk and information security management systems in the areas of engineering / plant management / operational support
– Expert activities in international large-scale plant construction
– Contract analysis
– Determining the current project status with subsequent results forecast for projects in international large-scale plant construction
– Checking technical and commercial reporting for plausibility and consistency
– Evaluating the reported project progress (technical / commercial) in comparison to the current project progress;
– Clarification of any causes of inconsistencies
– Verifying the causes for the creation and reversal of risk provisions as part of (project) risk management
– Quantitative risk analysis / risk aggregation using Monte Carlo simulation, among other things
Key data personally audited / assessed order volume in international large-scale plant construction:
– Number of projects > 85
– Number of construction site audits > 15
– Total contract value > € 15 billion
– Total project duration > 250 years
Professional Career
Managing Director
Systemic organizational consulting / consulting in the third mode
Supporting companies in the chemical and pharmaceutical process industry as well as international (large-scale) plant engineering in developing established quality, project, risk and information security management into high-performance and high-reliability organizations.
Thomas Makait QPRI, Hofheim am Taunus, since 2009 (part-time until 2012, full-time from 2012)
Senior Risk Manager / Partner
Management consultancy specializing in the process industry, mechanical and plant engineering
Euro Risk Limited, Zurich, from 2010 to 2014 (part-time from 2010 to 2012)
Quality manager for regulated computer systems
Pharmaceutical industry – biotechnological active ingredient production
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, 2006 – 2012
Technical Compliance Manager Engineering
Pharmaceutical industry – Chemical and biotechnological active ingredient production
Aventis Deutschland GmbH, Frankfurt am Main, 2002 – 2006
Manager Business Process Reengineering
Management consultancy specializing in the process industry, mechanical and plant engineering
KPMG Consulting AG, 1998 – 2002
Lead Engineer
international plant engineering, process plants
1994 – 1998 Residency and project management in Great Britain / London
Lurgi AG, Frankfurt am Main, 1991 – 1998
Industries and International Project experience
Process industry
– Petrochemistry / chemistry / fine chemistry
– Pharmaceuticals
– Food industry
and supply industry
– Mechanical and plant engineering
– Large-scale plant engineering
– System integrators / hardware suppliers / software developers
– Professional services
– Engineering service providers / engineering organizations (EO)
– Management consultancies
– Auditing companies
International project experience
– Audit experience in large-scale plant construction (Europe, USA, Middle East, Russia, India and North and South Africa)
– Business process reengineering projects (Europe, USA)
– Project experience in large-scale plant construction (Europe)
Languages, education and degrees
Languages
German (native)
English (fluent)
French (basic knowledge)
Training / qualifications
– Systemic Group Dynamics II [Inter-Group Dynamics]
2017 with Prof. Dr. Fritz B. Simon and Andreas Peteranderl;
Simon, Weber and Friends, Berlin
– Systemic Group Dynamics I [The Training Group]
2013 with Prof. Dr. Rudi Wimmer and Andreas Peteranderl;
Simon, Weber and Friends, Berlin
– Systemic organizational consultant
2012 – 2013 Training as a systemic organizational consultant,
Prof. Dr. Fritz B. Simon, Torsten Groth and Stefan Günther;
Simon, Weber and Friends, Berlin and Heidelberg
– Business Risk Manager – ISO 31000 / ONR 49000
2010 Euro Risk Limited, Zurich / Swiss TS Technical Services AG, Zurich
– Six Sigma+Lean Black Belt
2007 – 2008 In-house training Sanofi-Aventis / UMS GmbH
– Auditor Information Security Management Systems – ISO 27001
2006 Deutsche Gesellschaft für Qualität (DGQ), Frankfurt am Main
– Certified ICH Q7 Auditor
2005 API Compliance Institute, Heidelberg
– Auditor Quality Management Systems – ISO 9001
2004 Deutsche Gesellschaft für Qualität (DGQ), Frankfurt am Main
– Dipl.-Ing. (FH) Electrical Engineering, specializing in automation technology / control engineering
1987 – 1991 University of Applied Sciences, Darmstadt
– Fachabitur electrical technology
1986 – 1987 Werner von Siemens Fachoberschule, Frankfurt am Main
– Vocational training as a measurement and control mechanic IHK
1983 – 1986 Hoechst AG, Frankfurt am Main
Cooperation partners and Networks
Cooperation partner
– Dr. Kahla-Witzsch consulting in the healthcare sector
Professional exchange on the topics of risk management, project risk management and clinical risk management
– Frankfurt School of Finance & Management gemeinnützige GmbH
Frankfurt School is a research-driven business school covering all aspects of business, management, banking and finance Frankfurt School of Finance & Management
Certificate program: Certified Security Manager – Module Risk Management
– Helmut-Schmidt-Universität der Bundeswehr Hamburg
Institute for Automation Technology, Faculty of Mechanical Engineering
Research project: Large-scale projects in industrial plant engineering – How engineering organizations solve complex problems
– Interventions for Corporate Learning (ICL) GmbH
Professional exchange on the topics of systemic organizational consulting, systemic audits, High-Reliability-Organizing (HRO) as well as joint consulting and change projects in industrial companies High-Reliability-Organizing (HRO)
– Silvia Puhani – Consulting and support for internal auditing
Professional exchange on the topics of systemic organizational consulting and systemic reviews/audits Silvia Puhani
– VDI Technical Committee 6.12 Continuous engineering of control systems
Development of an “engineering maturity model”
How can the efficiency of engineering work be improved in a targeted manner? How can you get more certainty that investments in engineering tools are worthwhile?
These questions have been addressed by Technical Committee 6.12 “Integrated engineering of control systems” as part of its work since 2007. The aim is to develop an “engineering maturity model” that makes it possible to make a clear assessment of one’s own engineering activities with regard to various prerequisites for efficient engineering. On the basis of this assessment, specific measures can then be identified with regard to structure, processes and tools, the implementation of which offers great prospects of success in terms of improving engineering efficiency. Determining the “engineering maturity level” helps to make targeted use of potential for improvement and to make the right investments.
VDI Technical Committee 6.12 Continuous engineering of control systems
– VDI Wissensforum GmbH
The VDI Wissensforum has been a partner in further training for engineers and technical specialists and managers since 1957. The soft skills and management area rounds off the portfolio. More than 25,000 participants are trained and further educated every year with the help of the offer.
Seminar: Creating requirement and functional specifications for automation systems
Network
– AACE International (the Association for the Advancement of Cost Engineering)
With 8,500 members in 100 countries, AACE International has been serving the total cost management community since 1956. We are committed to the constructive exchange of ideas between members, development of technical guidance and quality education and recognition of subject matter experts.Our members work in a variety of disciplines and across all industries
AACE International
– Deutsche Gesellschaft für Qualität (DGQ)
Quality is our topic – and has been for more than 60 years. With 100 employees, around 6500 members and 200 trainers, the DGQ is today one of the largest quality management networks in Germany DGQ
– GPM Deutsche Gesellschaft für Projektmanagement e. V.
Promotion of project management, in particular training and further education as well as research and information in this field GPM
– ISPE D/A/CH
With more than 1,150 members in Germany/Austria/Switzerland, and growing, and around 20,000 members worldwide, it is one of the largest non-profit organizations in the pharmaceutical sector. Its members come from the fields of pharmaceutical production, mechanical and plant engineering for the pharmaceutical industry, engineering for pharmaceutical companies and independent engineering offices, consulting, universities and supervisory authorities ISPE D/A/CH
– PMI Germany – PMI Frankfurt Chapter e.V.
The PMI Frankfurt Chapter e.V. (PMIFC) is an independently founded non-profit association dealing with the knowledge field of project management. The chapter was founded in 1988 as the first European chapter and our members come from different parts of Germany. In addition to activities in the Frankfurt area, the chapter organizes itself in regulars’ tables and local groups such as Hanover or Hamburg
– Systemiker Map
The Systemiker Map arose from the idea of giving all graduates of the Simon, Weber and Friends courses the opportunity to network. The developing map serves on the one hand as a means of establishing contacts between colleagues, and on the other hand as an orientation aid for interested clients Systemiker Map
– VDI / GAMP D-A-CH Forum
VDI / Division 6: Engineering and operation of automated systems / 6.14
The aim and purpose of GAMP D-A-CH is to strengthen the acceptance, awareness and application of the current GAMP guidelines in the life science industry, suppliers and authorities in the German-speaking countries of Germany (D), Austria (A) and Switzerland (CH), to create a neutral platform for the exchange of information and to contribute to the further development and success of the GAMP guidelines GAMP D-A-CH
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