Thomas Makait
MTP4Pharma® - Plug & Produce for Smart Manufacturing - Intrinsic Quality & Compliance
Managing Director
Thomas Makait is Managing Director of
MTP4Pharma® - Plug & Produce for Smart Manufacturing - Intrinsic Quality & Compliance
His professional focus is the implementation of intrinsically compliant modular plant lifecycle processes based on the MTP-standard. Drawing on his experience of implementing modular plants, Thomas initiated and now leads the Global ISPE® GAMP® SIG MTP in Pharma – Modular Plant Validation and Qualification.
Thomas holds a degree in electrical engineering with a focus on control systems engineering.
From 1991 to 1998, he worked as a lead automation engineer on large-scale international chemical and petrochemical engineering, procurement and construction (EPC) projects.
Since 1999, he has worked in the pharmaceutical industry in various management positions in engineering, technical compliance and quality assurance.
Thomas is an active contributor to publications by VDI, NAMUR, PROFIBUS e.V. (PNO), ISPE®, GAMP® and GAMP® D-A-CH, as well as BioPhorum.
He is co-leading the creation of the upcoming ISPE® Pharma 4.0® GAMP® Good Practice Guide: Modular Plants According to MTP (Module Type Package): Technical Implementation and Computerised System Validation.
MTP4Pharma® - Plug & Produce for Smart Manufacturing - Intrinsic Quality & Compliance
His professional focus is the implementation of intrinsically compliant modular plant lifecycle processes based on the MTP-standard. Drawing on his experience of implementing modular plants, Thomas initiated and now leads the Global ISPE® GAMP® SIG MTP in Pharma – Modular Plant Validation and Qualification.
Thomas holds a degree in electrical engineering with a focus on control systems engineering.
From 1991 to 1998, he worked as a lead automation engineer on large-scale international chemical and petrochemical engineering, procurement and construction (EPC) projects.
Since 1999, he has worked in the pharmaceutical industry in various management positions in engineering, technical compliance and quality assurance.
Thomas is an active contributor to publications by VDI, NAMUR, PROFIBUS e.V. (PNO), ISPE®, GAMP® and GAMP® D-A-CH, as well as BioPhorum.
He is co-leading the creation of the upcoming ISPE® Pharma 4.0® GAMP® Good Practice Guide: Modular Plants According to MTP (Module Type Package): Technical Implementation and Computerised System Validation.