senior CSV Consultant – Tägerwilen CH / Athens GR

job description. 

 

As Senior Computer Validation Specialist you independently perform CSV projects in an international environment. You support projects or programs as Validation, Computer Validation or Test Lead, you develop validation strategies, and play a key role for our various clients in the pharmaceutical and medical technology industries.  

The ideal candidate will be able to demonstrate strong relationship management skills and will be able to handle challenging interpersonal situations.  

 The ideal candidate needs to be able to work as a CSV manager and independently run multiple simultaneous projects.  

Additionally, the ideal candidate will need to demonstrate a successful track record of budget monitoring, tracking and reporting.  

Lastly, the ideal person for this role will need be able to act as the single accountable person of running multiple, concurrent projects. 

 

your main responsibilities will be. 

  

Independent implementation of projects in the fields of IT / GxP Compliance, and Computer System Validation (CSV)  

Leading role in Quality /Compliance Management as part of national and international project teams - on-site at clients‘ locations from the Life Science Industry  

Managing role in validation of software-system projects, in accordance with regulatory compliance and through implementation of new tools - especially for SAP applications 

Execution of training and coaching in the areas of Computer System Validation (CSV), IT Compliance, and Test Management 

Integration, instruction, and management of our (Junior) Consultants during projects 

Development of strategic relationships with our project partners as a single point of contact 

Expansion of our customer network and support our established customer base 

 

requirements. 

  • Bachelor degree in natural sciences, business administration, computer sciences or higher 
  • Professional experience in implementation of complex validation projects, IT Compliance /CSV (with relevant knowledge in regulatory compliance processes in the areas of GxP and / or medical technology) 
  • Professional Experience in the area of Compliance (e.g. IT Compliance, CAPA Management, Change or Release Management) and knowledge of standards (e.g. 21 CFR 820, 21 CFR Part 11, ISO 14971) 
  • Several years active as CS QA,CSV Lead or similar 
  • Interest in project acquisition 
  • Interest in building up a near shore team (Athens) 
  • Systematic approach and good analytical skills 
  • High level of proficiency of the English language for effective communication with our national and international projects  
  • Excellent analytical thinking and high abstraction capabilities, quick perception, strong persuasive skills and creative power 
  • Excellent customer focus, strong social and networking skills 
  • Strong interpersonal skills and high enthusiasm 
  • Flexibility and mobility  
  • Experience working across projects with complex process interfaces, globally distributed sites functions/sites, and overall high risk 

 Nice to Have Skills: knowledge in Serialization for Pharmaceuticals, Familiarity with SAP system and specific SAP CSV requirements 

 

The position is permanent and is based in Tägerwilen Switzerland or Athens (Glyfada) Greece. 

 

we offer. 

 

Competitive compensation packages 

Comprehensive training programs 

A stimulating and multinational work environment 

Opportunities to work abroad 

Very good career advancement opportunities 

Group Health Insurance 

Business mobile 

 

The place of work is primarily at our clients’ locations, while our headquarters in Tägerwilen (Switzerland) or Athens (Greece) serve as central offices. 

 

contact details. 

 

Please send an up-to-date CV and your motivation letter to info@i2b-gmbh.ch explaining how your experience to-date meets the above requirements and why you believe you are the right candidate for the role described. Please make sure you cover the above requirements with relevant examples from your previous roles.