Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees.
An opportunity has arisen for an IT System Engineer/Validation specialist to join our Livingston site
The System Engineer (SE) is responsible for definition design, installation and validation of computerized systems.
This individual drives site validation projects (with focus on IT activities) and contributes in all definition, process mapping and development activities with regards to new or existing computerized systems.
This individual Acts as a bridge between Users, IT department and Vendors, supports the QA, manufacturing, QC, CTM, personnel during projects and operations and ensures that system hardware, operating systems, software systems, and related procedures adhere to corporate structures.
This individual aligns with local users, project teams and site management to ensure that local and global IT systems available on site work properly and projects are implemented efficiently and in alignment with local and global policies and procedures.
This individual works closely with corporate IT to ensure that local requirements are aligned with global systems and that local and global systems used on site meet the end user demands.
This individual liaises with external vendors to ensure that external resources (services and assets) are available when needed and used/purchased efficiently.
- Ensures proper design, implementation and validation of computerized systems
- Contributes to and keeps validated state of GxP applications
- Participate in system validation projects, drive the IT activities within these projects
- Coordinates inter-site communication and activities with regards to global IT systems
- Supports the business owners during the whole life cycle of computerized systems
- Responsible for the definition, validation and operation for locally managed IT systems, mainly
- Laboratory information management system (LIMS)
- Documentation management systems (electronic batch management)
- Planning and resource allocation system
- Liaise with external vendors
- Profound IT background and IT skills needed
- Excellent skills Validation of (computerized) systems are needed
- Excellent knowledge of GAMP 5 and ITIL processes needed
- SQL, AD and Microsoft environment knowledge is an asset
- University degree in IT or comparable education
- At least 3 years experience in a comparable organization
- Project management expertise is an asset