CSV Engineer French-English
vor 3 Wochen
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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