COO, Partner & Senior Consultant

• Jan 2022 - Present

Genau & More is a highly specialized consulting company solely working in Life Sciences. We offer specialist knowledge and resources at senior level within compliance, regulatory, quality assurance & control, manufacturing processes and GMP IT & Automation. At Genau & More we are striving to build and develop long-term relationships with our clients build on trust. Jointly with our clients, we lead the field of compliance & quality and together we shape a future based on collaboration-driven excellence. Compliance & quality is a shared dedication.Examples of project achieved results:• New Product Development project (Medical Devices - Embedded Software)• Inspection readuness assessment of cloud-based SaaS solution (Pharmaceutical & Medical Devices) Show less

Senior Consultant and Manager, IT & Automation

• Jan 2021 - Jan 2022

Genau & More is a highly specialized consulting company solely working in Life Sciences. We offer specialist knowledge and resources at senior level within compliance, regulatory, quality assurance & control, manufacturing processes and GMP IT & Automation. At Genau & More we are striving to build and develop long-term relationships with our clients build on trust. Jointly with our clients, we lead the field of compliance & quality and together we shape a future based on collaboration-driven excellence. Compliance & quality is a shared dedication.Examples of project achieved results:• New Product Development project (Medical Devices - Embedded Software)• New Tech R&D bring-up project (Medical Devices - Embedded Software)• Process transition and change project for development department (Medical Devices - Hardware and Software) Show less

Consultant and Manager, IT & Automation

• Feb 2019 - Dec 2020

Genau & More is a highly specialized consulting company solely working in Life Sciences. We offer specialist knowledge and resources at senior level within compliance, regulatory, quality assurance & control, manufacturing processes and GMP IT & Automation. At Genau & More we are striving to build and develop long-term relationships with our clients build on trust. Jointly with our clients, we lead the field of compliance & quality and together we shape a future based on collaboration-driven excellence. Compliance & quality is a shared dedication.Examples of project achieved results:• Process transition and change project for development department (Medical devices - Hardware and Software)• Laboratory equipment software validation project (Medicinal Cannabis)• Data Mapping of production preparing for artificial intelligence• Proff of Concept project utilizing existing data through AI for optimization of 4 production processes Show less

Project Manager

• Jan 2017 - Jan 2019

Automation and IT Portfolio Project Manager for a group of 10-15 engineers within Automation and IT. Responsible for setting the project direction, managing the economy and stakeholders (internal and external), developing and executing project plans and finally ensuring correct compliance and validation levels.Examples of achieved results:• Developed Automation and IT portfolio to 15 engineers• Cleaning upgrade project (Brownfield): 10 Engineers (Automation and IT)• Cross-displinary project – change of control system: 12 Engineers (Mechanical, Electrical, Instrumentation, Procurement, Quality, Automation and IT)• Conceptual design and startup of main project on multi-line upgrade to run 3 different products in campains Show less

Lead Automation Engineer

• Aug 2015 - Dec 2016

Technical Lead Engineer for a group of approx. 8 engineers within Automation and IT. Responsible for setting the technical direction, calculating costs and controlling the economy, developing and executing project plans and finally ensuring and coordinating cross-disciplinary interfaces.Examples of achieved results:• Established Automation and IT portfolio with 8 engineers• Optimization project (Brownfield): 7 Engineers (Automation, IT, Mechanical, Quality)• API bulk installation of new centrifuges: 5 Engineers (Automation and IT) Show less

Automation Engineer

• Aug 2013 - Jul 2015

Student Assistant

• May 2011 - Jul 2013

In Device R&D I helped develop, build and test various test equipment for medical devices. Besides I wrote my Master's Thesis in collaboration with the department. In Device R&D I helped develop, build and test various test equipment for medical devices. Besides I wrote my Master's Thesis in collaboration with the department.