Projects and References

Project GMP guidance

Project GMP guidance
Site Country: Denmark
Client Headquarter: Germany
GMP Specialist
Responsible for GMP guidance to project managers regarding the management and qualification of major rebuilding projects Updating and instruction in use of, site GMP tools and templates. Planning and holding of GMP seminar.
BASF A/S, site Ballerup. 2017

Purification Recovery upgrades

Site Country: Denmark
Client Headquarter: Denmark
GMP Specialist
Responsible for data review and Qualification & test on updates in Purification Recovery systems, including tanks and clean utility piping. Primary task are data review.
Novo Nordisk A/S, site Bagsværd. 2016-17

Greenfield project

Site Country: Denmark
Client Headquarter: Denmark
Senior Project Manager
Validation senior project manager. Responsible for Qualification of Greenfield warehouse facilities for pharmaceutical raw materials. Primary task are management of the qualification process and related documents.
Novo Nordisk A/S, 2014 – 2016

Incubation rooms in existing production facility

Site Country: Denmark
Client Headquarter: Denmark
Senior Project manager
Responsible for construction of two Incubation rooms. Primary task are stakeholder management and management of construction and qualification process and related documents.
Novo Nordisk A/S. 2015-2016

Sunflower oil evaporation

Site Country: Denmark
Customer Headquarter: Sweden
Project Manager
Project Manager in Evaporation department, sanitary & food technology process equipment. Responsible for Project management, design and construction. Primary task are management of design and construction activities.
Alfa Laval, 2013 – 2014

Clean Utility systems

Site Country: Denmark
Client Headquarter: United States
Construction Manager and Project Manager
Project Manager / Construction Manager in a pharmaceutical production environment. Main task are management of upgrades on Clean Utility systems and production equipment. Primary task are management and supervision of suppliers installing utilities, and Installation Qualification. Production of Standard Operating Procedures (SOP).
NNE Pharmaplan/Biogen Idec, 2012 – 2013

Revamp. – Insulin purification plant

Site Country: Denmark
Client Headquarter: Denmark
Project Engineer
Revamp and installation of new equipment. Coordination and supervision of suppliers. Keeping the deadlines
and following up according to time schedules.
Novo Nordisk A/S, 2012

Turnkey, – Pharmaceutical testplant

Site Country: Belgium
Client Headquarter: Belgium
Piping supervisor
Project engineer and Piping supervisor. Responsible for clean utility systems. Primary task are management and supervision of suppliers.
UCB S.A., 10/2011-5/2012

Conceptual – Flue gas filtration

Site Country: Sweden
Client Headquarter: Sweden
Construction Manager
Project manager. Responsible for management of construction. Primary task are stakeholder management, construction management and supervision of suppliers.
Perstorp AB, 8/2011-10/2011

Installation of new equipment – Insulin purification plant

Site Country: Denmark
Client Headquarter: Denmark
Project Engineer
Responsible for management of changes in Clean Utility and production equipment in a pharmaceutical production equipment. Primary task are management of stakeholders and suppliers, inspection on site, receiving inspection and installation qualification.
Novo Nordisk A/S, 2011-2011

Building a new plant – Aseptic Filling Facility

Site Country: China
Client Headquarter: Denmark
Project Engineer
Qualification support engineer. Responsible for Clean Utility systems. Primary task are management and supervision of subcontractors, management and supervision in relation to Qualification of “As-built” drawings and welding documentation.
Secondary task are preparation of Installation Qualification reports in Validation software eTIMS. Managing training and guidance of Chinese construction engineers and GMP test personnel.
Novo Nordisk A/S, 2010

Other relevant experience

Project Manager
Project manager. Responsible for Procurement & Logistics. Primary task are procurement of stainless components and raw materials. Management of suppliers and contracts. QA function, inspection and preparation of documentation according to GMP.
EMF EnvitoTec A/S DK, 2007-2010

Purchaser and QA Inspector
QA Engineer on customer- and supplier sites in Europe.
Qualification of equipment according to cGMP.
Responsible for the FAT of process equipment including documentation.
NDT inspection according to EN 473 level 2.
Procurement of services and products for use in cGMP production.
Selection of suppliers.
Contract and price negotiations.
Completed projects in the order of €100,000.
Aftermarket manager.
GEA Niro A/S DK, 2000-2007