Beschreibung
Software Validation and Verification SupportRole/ Project:
For one of our clients, we are looking for a development engineer for mechanics who will develop mechatronic real-time system components embedded in several projects.
Main Tasks:
In this function, you support the project manager in the documentation and qualification of the ongoing project as well as in developing the support capability in the various milestones.
The task area is divided into two areas, each of which is weighted differently :
Main activities (80%) :
-Validation / documentation and qualification of the biochemical raw data generated in the project towards the end of the sub-processes.
-Creation of test plans for testing the software and scripts that control test / test procedures in development
-Validation of test software and test scripts as well as Excel workbooks according to CSV (Computerized System Validation), which Ensure test procedures / results from the development environment and link them to databases
-Qualification of test / test systems (custom built, consisting of various subsystems)
-Requirements Management (contact with stakeholders to define URS)
-Change Board
-Training setup Lead
Secondary employment (20%):
-Development of the support basics with the information from the last partial processes and the further evaluation of the received project specific data with regard to further coordination in the project. Furthermore, you are the contact person for the technical advice of the operators and users of the equipment / systems.
-Project coordination, collaboration, planning and coordination of priorities in meetings with production and project managers from RMD Development in particular orders to custommade test systems
-Documentation of validation / qualification activities according to internal manufacturing process according to valid specifications and project planning
-Risk analysis for equipment / software / systems
-Support and technical advice to operators and users of equipment / systems when carrying out validation and qualification tasks
Requirements:
-Experience in writing process documentation or qualification documentation
-2-5 years experience in validation, (qualification and CSV Computer System Validation) or near validation and Training programs
Nice to have :
-MS Office / HP ALM / TFS (Team Foundation Server)
-Previous experience in medical technology (ISO 13458, GMP, FDA 21 CFR 820) or GxP experience
-Introverted working technique with communicative flair within the line / stakeholder
-Abstract thinking for the recognition of complex relationships
-Software understanding
Education:
-At least one university degree in engineering, medicine or biophysics or completed training with at least 2 years experience in process management and development of Project documentation in the affiliated departments of Technology, Medicine, Biology / Chemistry
Language:
-Fluent in English
-German is nice to have
_______________________________________________________________________________________
Reference No.: 918748NC
Role: Software Validation and Verification Support
Domain: Pharma
Location: Lucerne
Workload: 100%
Start: 01.02.2020
Duration:
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