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  Profile & Competences  
       


Profile


I, Jeppe Kjems, is the Director of CU Engineering and Critical Utility Specialist within the pharmaceutical industry.  

Having completed a M.Sc. in Dairy Engineering and Engineering Technology Management and with +25 years of international experience, of which +20 years are within the Pharmaceutical and Biotech industries, I posses broad experience ranging from the production floor to top management.  

Due to my change management experience gained from various organizations, cultures and countries, I have the ability to make a significant difference on projects or in a busy production environment.

My work ethics are based on reliability, optimism and life energy and I put big effort into making dreams and goals come true.

 

Key competences

Project Management
I have extensive project management experience covering all project phases from Client Brief to Handover and Specialist knowledge on Sanitary Design, cGMP and regulatory requirements. 
My Specialist knowledge comes from working more than 20 years with Sanitary and GMP critical design, supervising projects, as well as participating in regulatory audits and conducting supplier audits.  

Subject Matter Expert
Many years of international experience working with Critical Utilities at all levels from the production floor to top management. Working as a Peer Reviewer and a Clean Utility Specialist at Novo Nordisk has contributed to the qualification as a Subject Matter Expert according to 鳫 Based Validation殢sp;
Also, presenting at International and Domestic conferences e.g. International Society of Pharmaceutical Engineering (ISPE), R-3 and the Danish Technical University has added to this skill-set.

Process optimization
Due to Novo Nordisk೴rong focus on the environment and sustainable production methods, significant water and energy savings have been uncovered most of them with good pay back times.

Microbiological background
My microbiological background combined with a strong technical expertise has often shown to be the key when trouble shooting 崠Of Specification튳ituations or performing ᩬure Investigations쯳pan>

Other qualifications:

ﳰan>          Clean Utility (CU) Specialist at Novo Nordisk A/S with responsibility for global CU technology network and worldwide support of CU production units. CU production units to comply with European Medical Agency (EMEA), American FDA, Japanese- and Chinese Pharmacopoeias.

ﳰan>          Strong leadership credentials and experience from managing various technical areas (managed up to 40 professional engineers) as well as performing project committee work.

ﳰan>          Strong strategic overview and comprehensive business understanding.

CU Engineering is a small company that works closely with a strong network of consultants enabling us to have a flexible approach to project scope. CU Engineering has strong experience with Process and Equipment Design, Process Automation, Equipment and System Installation, Commissioning and Qualification (DQ/IQ/OQ/PQ).


 

 


     Key Competences:


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