CSV Engineer French-English

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.
Vor 4 Tagen