Computerized Systems Validation Consultant

• You develop the validation strategy and carry out validation activities on an R&D site or a production plant (Bio-Tech).
• You prepare ‘high level’ documents (Validation master plans, criticality analysis), protocols and scripts, procedures and reports, up to the final delivery.
• You may be conducted to supervise a team of validation engineers in the execution of validation activities.
• You strictly work according procedures and guidelines.
• You report on the progress of these validation activities to the project manager.

• You preferably have at least a master or engineer’s degree in a technical or scientific field, linked to life sciences.
• You have 5 years of experience with computer validation in a GMP environment and you know how to use some of its associated applications (ex.: MES, ERP, LIMS, EBR, QMS/eDMS, etc.).
• You have broad/general knowledge on computerized systems and automation (ex.: data security, data exchange, infrastructure, PLC, SCADA, MES-systems, ERP, etc).
• You are familiar with working according GAMP 5, and aware of current insights regarding 21 CFR-part11.
• You are able to work precisely and accurately and in accordance to specific guidelines and rules (ex. GMP, GLP).
• You have good communication skills at different (social) levels.
• You are self-reliant and organized, with a team spirit.
• You have experience with MS Office.
• You express yourself fluently in Dutch and English, oral and written.

• To work in a dynamic environment where you can give free rein to your inventiveness within a well-defined framework.
• To have the possibility to team up with passionate, quality on technology-driven people.
• To develop yourself in a learning environment that offers the potential for career development.
• To be part of a company culture where respect, knowledge sharing, open mind, allow to strive for excellence.