References

Mobirise
Critical Utility SME for Vaccine Manufacturing

Subject Matter Expert (SME) on PQ3 of Critical Utility systems (WFI, PS, Sterile Gasses) for a Pharmaceutical Sterile facility - TIC DKK 500 million.
Bavarian Nordic A/S, Denmark - (2019-2020)

Mobirise
Critical Utility SME for Tablet Manufacturing

Subject Matter Expert (SME) on PQ3 of Purified Water system for a Novo Nordisk A/S
Pharmaceutical Tableting facility.
Niras A/S, Denmark - (2018-2019)

Mobirise
Subject Matter Expert (SME) - Critical Utility and CIP

Green field Pharmaceutical Tableting facility for Novo Nordisk A/S
– TIC DKK 1.0 billion.
Niras A/S, Denmark - (2015-2018)

Mobirise
Critical Utility lead for Basic Design

New Pre-Treated-Water (PTW), WFI and Clean Steam Systems to be exchanged in existing Pharmaceutical Filling Plant.
– TIC DKK 42 million
NNE Pharmaplan A/S, Denmark - (2015)

Mobirise
Technical Support during Basic Design

CIP/SIP User Responsible for Novo Nordisk A/S during the BD of a new Pharmaceutical Filling Plant.
– TIC DKK 2.1 billion
Alectia A/S, Denmark - (2015)

Mobirise
Facility Review and Technical support of Critical Utilities

Subject Matter Expert (SME) for Critical Utility Systems for Pharmaceutical Filling Plant.
Exir Pharmaceutical Co, Iran - (2014)

Mobirise
Technical Support

Subject Matter Expert (SME) support for Pure Steam System Insulin Filling Plant.
Novo Nordisk Pharmaceuticals SAS, France - (2013)

Mobirise
Technical Support

Subject Matter Expert (SME) support for Design, Installation and Validation of new Supply Water System for API production.
Novo Nordisk A/S, Denmark - (2013)

Mobirise
Technical Support

 Subject Matter Expert (SME) support for Purified Water in API facility.
PolyPeptide Laboratories Ltd., Sweden - (2013)

Mobirise
Audit High Purity Water systems

Subject Matter Expert (SME) support for audit of Purified Water and WFI System for Insulin Filling Plant.
Eskayef Ldt., Dhaka, Bangladesh - (2012)

Mobirise
Pure Steam Generator project

Project Manager and Subject Matter Expert (SME) for Front-end design, Installation and Validation of a new Pure Steam Generator in Insulin filling Plant.
Novo Nordisk A/S, Denmark - (2012-2013)

Mobirise
Member of International Society of Pharmaceutical Engineering (ISPE)

ISPE Global CU steering committee, member (2011-2015)
ISPE Nordic CU steering committee, chairman (2013-2015)
Global CU network - (1994-2017)

Mobirise
Process Performance Qualification of API

Support for the preparations of the Process Performance Qualification (PPQ) – a green field project for an Active Pharmaceutical Ingredient (API) production.
Novozymes A/S, China - (2011)

Mobirise
Validation of Purified Water system

Subject Matter Expert at commissioning and Qualification of a Purified Water system – a green field project for API production.
PolyPeptide Laboratories Ltd., India - (2011-2012)

Mobirise
Audit of Clean Utility systems

Technical audit responsible at Critical Utility assessment of Insulin Filling plant.
Torrent Pharmaceuticals Ltd, India - (2011)

Mobirise
PQ of Clean Utility systems / production support

Responsible for preparation and execution of the PQ for WFI, Critical Steam and Process Air (sterile compressed air) on a new Insulin Filling plant, securing the robustness of production equipment /Critical and coaching of the Chinese personnel.
Novo Nordisk A/S, China - (2010-2012)

Mobirise
De-rouging of High Purity Water system

Environmentally friendly De-rouging of a High Purity Water system without use of detergents.
Novo Nordisk A/S, Denmark - (2010)

Mobirise
Clean Utility Specialist

Chairman for Novo Nordisk DFP Global Clean Utility Technology group. Optimization, Water & Energy saving and cLEAN production. Participated in Pre-FEED and FEED, Trouble shooting / Failure Investigations, Commissioning & Qualification (DQ/IQ/OQ/PQ). Provided project support for Greenfield Insulin Filling Plant, China. Speaker at International and Domestic CU conferences.
Novo Nordisk A/S, Denmark - (2008-2010)

Mobirise
Senior Project Manager - Insulin Filling Plant

Responsible for Clean Utilities & CIP/SIP installations as well as the product transfer of NovoMix30 from DK to Brazil, budget responsibility DKK +100 million.
– TIC DKK 1.700 million.
Novo Nordisk A/S, Brazil - (2004-2008)

Mobirise
Health Care Fermentation - Fermentation Chemist

Support for NN2211 IVa Campaign in Pilot Plant and production for Clinical Phase III in Kalundborg. The product Victoza was launched in Europe, Japan and the US 2009/2010.
Novo Nordisk A/S, Denmark - (2002-2003)

Mobirise
Health Care Insulin Pilot Plant, 20 liters fermenters

NNE project committee representative. I was overall responsible for the total project delivery to the customer's satisfaction (quality, price and time). The project was executed under operating conditions.
– TIC DKK 32 million.
Novo Nordisk A/S, Denmark - (2001-2002)

Mobirise
Health Care Insulin Launch Plant, modification

NNE project committee representative. I was overall responsible for the total project delivery to the customer's satisfaction (quality, price and time). The project was executed under operating conditions.
– TIC DKK 35 million.
Novo Nordisk A/S, Denmark - (2001-2002)

Mobirise
Health Care Insulin Pilot Plant, Multicolumn modification

NNE project committee representative. I was overall responsible for the total project delivery to the customer's satisfaction (quality, price and time). The project was executed under operating conditions.
– TIC DKK 9 million.
Novo Nordisk A/S, Denmark - (2001-2002)

Mobirise
Health Care Cell Cultivation Pilot, Upgrade nGMP to GMP

NNE project committee representative. I was overall responsible for the total project delivery to the customer's satisfaction (quality, price and time). The project was executed under operating conditions.
– TIC DKK 24 million.
Novo Nordisk A/S, Denmark - (2001-2002)

Mobirise
FEED / CIP-systems for Fermentation facilities

Project Manager
Perform analysis including logistics for two new CIP-system designs for two complete fermentation plants, BC & BD in Kalundborg.
Novo Nordisk A/S, Denmark - (1997)

Mobirise
Health Care Insulin Filling, WFI system

Project Manager
Production capacity analysis of WFI Still and distribution system.
Design, Installation, Commissioning & Qualification and Handover of a new WFI-system.
Novo Nordisk PII, North Carolina US. - (1995-1996)

Mobirise
Health Care Insulin Filling, WFI-system

Project Manager
Design, Implementation and Validation of a new WFI system in an existing production. The primary tasks were to complete the design and installation of the system, as well as Commissioning and Qualification under an accelerated schedule, which succeeded.
Novo Nordisk A/S, Denmark - (1994-1995)

Mobirise
Health Care upgrade and retrospective validation of CU systems

Project Engineer
Writing and execution of IQ test plans as well as writing SOP's.
Novo Nordisk A/S, Denmark - (1993-1994)

Mobirise
International experiences

I have worked in the following countries for more than one month:
China, Brazil, Guatemala, US, Norway, Jordan, Australia, Uganda and Tanzania.

Address
  • Ydervang 11
  • DK-3460 Birkerød
  • Denmark
Phone
  • +45 42 40 11 09