CSV Engineer FrenchEnglish

• You provide support and expertise on Computer System Validation activities
  
• You run CSV projects execution ensuring timelines are met
  
• You write validation plan URS FS risk assessment IQ/OQ/PQ protocols reports VSR applicable SOPs and training documents
  
• You train and coach people
  
• You maintain expertise in current and emerging cGMP requirements and quality trends
  
• You work independently and successfully solve problems and complete/qualify a system within given constraint of scope time and schedule
  
• You lead system qualification efforts and are the primary client contact for coordinating work reporting status resolving issues and addressing change orders as they apply
  
• You develop new and pragmatic approaches to support the industry in this field
  

Requirements

• You hold a Master s degree in a scientific or engineering discipline
  
• You possess at least 3 years of experience in the field of computer system validation that you developed in Pharmaceuticals Biotechnologies or Medical devices industries
  
• You have experience with all pertinent industry best practices (GAMP 5 etc.) including development and execution of all applicable system life cycle deliverables (e.g. URS SRS FRS DDS RTM Unit Integration User Acceptance testing FAT SAT Validation Planning IQ OQ PQ Final Validation Summary Report)
  
• You have previous automation experience and experiences with MES ERP and LIMS
  
• You possess experience in project execution within at least one area of systems validation e.g. laboratory equipment facilities utilities manufacturing equipment metrology equipment information systems
  
• You are fluent in French with good knowledge of English
  
• You are willing to work in Switzerland
  

Benefits

• Very competitive compensation package with exceptional Pension scheme.
  
• 5 weeks paid holidays.
  
• ongoing Training & Development opportunities.