Our client is a professional Biotechnology and Pharmaceutical organization, based in Noord-Brabant Netherlands.
Within the company you will be part of an international working environment within the IT Business Unit.
For the implementation of a Manufacturing Execution System my client is looking for a specialist with extensive experience with MES in regulated production environments. This concerns a freelance project of 9 months, for which I'm looking for somebody who is available on a short notice. During this project you will be responsible for the daily support of the implementation, but also for the analysis of the capabilities and the requirements design of the system. The project requires somebody who can work within multidisciplinary environments on a global scale in order to ensure the timely delivery of the system and a high quality standard.
Responsible for System Design and Solutions
2nd and 3rd line support for System Development
Compliancy with FDA regulations 21 CFR Part 11
SOPs for system administration
Maintenance and development of Configuration and Design Specifications
Project Documentation for system changes
BSc. in Information Technology, Life Sciences, Engineering or similar
6 years’ experience with Information Systems
4 years’ experience with Development of Applications
Strong knowledge of Manufacturing Execution Systems (e.g. OPC)
Previous experience with Validation, Change Control, Testing and Enterprise Systems
Experience with a Document Management System
Professional experience in GMP environments
Bio-pharmaceutical experience is a strong plus
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