We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our focused pipeline includes the world’s first vaccine against the chikungunya virus, the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

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Our IT team are currently recruiting for a System Engineer/ Validaton Specialist to be responsible for the definition design, installation, and validation of computerised systems.

• 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.
• Acts as a bridge between Users, IT department and Vendors, supports all involved stakeholders and personnel during projects and operations and ensures that system hardware, operating systems, software systems, and related procedures adhere to corporate structures.
• 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.
• 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.
• Liaises with external vendors to ensure that external resources (services and assets) are available when needed and used/purchased efficiently.

Requirements

Responsible for the implementation, proper design with system owners, the validation and operation of locally managed electronic systems and computerized systems, mainly

• Laboratory information management system (LIMS)
• Documentation and quality management systems (incl. electronic batch management)
• Maintenance & calibration systems
• Any other local departments Computerised Systems

Participate in system validation projects, drive the IT activities within these projects

Contributes to and keeps validated state of GxP applications

Coordinates inter-site communication and activities with regards to global IT systems

Supports business owners during the whole life cycle of computerized systems

Liaise with external vendors

Experience

• University degree in IT or comparable education
• Experience with GAMP 5 and ITIL processes required
• Excellent Validation skills of (computerized) systems are needed
• Profound IT background and IT skills needed
• Project management expertise is an asset
• SQL, AD and Microsoft environment knowledge is an asset

Benefits

• Stock Options
• Employee Assistance Programme
• Gym membership OR fitness allowance
• Free Fruit
• Many others included