week of 19/9
The Senior IS engineer provides operational support for computerized systems in a GMP (Good Manufacturing Practices) regulated atmosphere and will be responsible as a system owner for deploying software, incident management, problem management, klife-cycle management, system maintenance including application upgrades, projects, enhancements and security patches. Your proven overall IT and engineering knowledge, communication skills and project Management experience will enable you to liaise effectively with clients, users and IT experts (application, network, database, etc.) locally as well with other sites worldwide in order to provide IT solutions for clients.
The Senior IS engineer coordinates small projects or serves as a project member in larger projects. Has the discipline and technical knowledge to work independently and take on responsibilities. Designs and deploys new innovative solutions to improve the efficiency of business processes. Ensures procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements. Works with other IT and engineering experts, vendors and customers to ensure regulatory (e.g. validation), business, functional and application specific requirements are met.
10 years of Information Systems (IS) experience preferable within the pharmaceutical or biotech industry.
10 years of experience with installing, testing and deploying new IT solutions in an Engineering environment
Experience in automation or equipment engineering combined with Information Systems (IS)
Knowledge and experience with Building Monitoring systems
Knowledge and experience with environmental monitoring systems
Knowledge and experience with Warehouse applications (Miniload)
Knowledge of ITIL fundamentals in Service operations and Application life cycle processes
Knowledge of change management and validation of computerized systems (e.g. GAMP5)
Fluent in English (both verbal and written)
Excellent organization skills, detail oriented and accurate
Skilled in working under pressure, must possess good time management skills
Able to communicate ideas in both technical and use-friendly language
Experience in developing and executing SOPs, Installation and Operational (IQ, OQ) Protocols
Experience in working with solution lifecycle methodologies e.g. Agile and RUP
Experience as a project-manager in implementing IT solutions on an application level
Used to System Change Management procedures in a complex controlled environment
Has an Innovation mindset not only in words but also in actions
Ability to work in global, cross-functional and virtual teams in different time zones (flexibility in work hrs)
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