CSV Engineer
- Catégorie: Chimie / Bio / Pharma, IT
- Type de contrat: CDI
- Localisation: Lausanne, Suisse
- Niveau de formation: Master/ingénieur
- Expérience/Années: > 3 y
Mission
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
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 S ummary 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