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Profile & Competences
References
CV
Contact
   

References

 
    Subject Matter Expert (SME) - Critical Utility and CIP
Green field Pharmaceutical Tableting facility for Novo Nordisk A/S - TIC DKK 1.0 billion.
Alectia A/S, Denmark - (2015- ) 
     
    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) 
     
    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)
     
    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)?
     
    Technical Support
Subject Matter Expert (SME) support for Pure Steam System Insulin Filling Plant.
Novo Nordisk Pharmaceuticals SAS, France - (2013) 
     
    Technical Support
Subject Matter Expert (SME) support for Pure Steam System Insulin Filling Plant.
Novo Nordisk Pharmaceuticals SAS, France - (2013) 
     
    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) 
     
    Technical Support
Subject Matter Expert (SME) support for Purified Water in API facility.
PolyPeptide Laboratories Ltd., Sweden - (2013) 
     
    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) 
     
    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) 
     
 


 

ISPE Global CU steering committee member
Member of International Society of Pharmaceutical Engineering (ISPE) global steering committee Critical Utilities. 
Global CU network - (2011- ) 

 


 


 

 

 
 


 

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)

 


 


 

 

 
 

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)

   
 

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

   
  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)
   
  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 - (20
10)
   
  Clean Utility Specialist
Chairman for Novo Nordisk DFP Global Clean Utility Technology group.
Optimisation, 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)
   
  Senior Project Manager - Insulin Filling Plant
TIC DKK 1.700 million.

Responsible for Clean Utilities & CIP/SIP installations as well as the product transfer of NovoMix30 from DK to Brazil, budget responsibility DKK +100 million.

Novo Nordisk A/S, Brazil - (2004-2008)
   
 

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)

   
 

Health Care Insulin Pilot Plant, 20 liters fermenters
TIC DKK 32 million.

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.

Novo Nordisk A/S, Denmark - (2001-2002)

   
 

Health Care Insulin Launch Plant, modification
TIC DKK 35 million.

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.

Novo Nordisk A/S, Denmark - (2001-2002)

   
 

Health Care Insulin Pilot Plant, Multicolumn modification
TIC DKK 9 million.
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.

Novo Nordisk A/S, Denmark - (2001-2002)

   
 

Health Care Cell Cultivation Pilot, Upgrade nGMP to GMP
TIC DKK 24 million.

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.

Novo Nordisk A/S, Denmark - (2001-2002)

   
 

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)

   
 

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)

   
 

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)

   
 

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)

   
 

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

   
  CU Engineering - Ydervang 11 - DK-3460 Birker? - Denmark - +45 42 40 11 09 - jk@cu-engineering.dk   Voluntary Projects