CSV Engineer French-English

1 month ago

india EURHASI Full time
Job Description

EURHASI is recruiting for its client a CSV Engineer French-English

Our client is a Swiss consulting company composed of a passionate team of experienced Life Sciences professionals.

Since 2014 our client delivers outstanding industry’s expertise and support to their clients in the complete product life cycle such as: R&D, Engineering and Construction, Quality management (Quality Assurance, Qualification/Validation, QC,…), Regulatory Affairs, Manufacturing, Maintenance, Operational Excellence, and Project Management.

 

Information  : The client accepts applications requiring administrative procedures for a work authorization (residence permit, work permit, various authorizations, etc.) under certain conditions: EU/EFTA member state nationals only.

 

Mission

About the job:

  •             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

Profil

Profile

  • 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

 

Minimum expected qualifications :

  • The candidate must be willing to work in Switzerland
  • at least 3 years of experience in the field of computer system validation that you developed in Pharmaceuticals, Biotechnologies or Medical devices industries
  • Fluency in English

 


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

 


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