Your technical environment
Joining FORTIL Switzerland means joining a team of experts, business engineers and recruiters. Established in Geneva, our expertise is in Energy, Transport and Life Sciences.
FORTIL guides start-ups and big groups and meet their needs by providing skilled and talented project teams and individual consultants. We deploy custom-made solutions to offer relevant advice and we put our know-hows and recruitment experiences to the service of our clients’ projects.
Your job responsibilities
- You will provide support and expertise on Computer System Validation activities
- You will execute and/or support and/or review Computer System Validation (CSV) activities including creation, review and approval of validation documentation and work instructions on various systems
- You will perform QA reviews and approvals of all validation related documentation such as Validation Plan, User Requirements, IQ, OQ, PQ, Plan and Traceability Matrix, etc..
- You will Reviewing and releasing CSV documents and SOPs
- You will assist in maintaining the systems in a validated state
- You will support all departments during regulatory inspections and audits
What you need to succeed
• 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,)
• You have previous automation experience and experiences with MES, ERP and/or 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 and English
Your profile and personality
Master’s degree in scientific or engineering discipline and minimum 4 years of experience in the field of computer system validation than you developed in Pharmaceuticals, Biotechnologies or Medical devices industries