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Roche Diagnostics in Rotkreuz (ZG), the world leader in in-vitro diagnostics, is looking for a motivated individual with first experience and good technical understanding of product development processes within a highly regulated environment
Engineer / Process Supporter (a)
The Department Design Control Excellence is looking for an Engineer (Process Supporter) with a good understanding of development processes. The Engineer (Process Supporter) is responsible for process guidance, process optimization and documentation of various development projects.
* Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration Management and/or Verification & Validation Management
* Support translation of multi-level requirements via Requirements Management process
* Conduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representatives
* Ensure all risks and requirements are maintained within a database and streamline approach across projects
* Ensure the delivery of timely and good quality risk and requirements documentation
* Establish and perform Configuration Management in complex development projects
* Support development projects as Verification Manager (Planning, Guiding, Training, Reporting)
* Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments.
* Information gathering from respective stakeholders including consolidation of information
* Independent execution of work packages within area of responsibility
* Organize and manage own time within scope of assigned work packages
* Ensure the delivery of timely and good quality documentation
* University degree in Life Sciences, Natural Sciences or Engineering
* First experience and good technical understanding of product development processes within a highly regulated environment
* Experience in Process Management (Risk-, Requirements-, Configuration-, Defect and/or Verification Management) is a plus
* Experience in the Diagnostics industry and experience within the GMP regulated environment is a plus
* Excellent verbal and written communication skills in English, and preferably German in addition
* Database experience preferred
Your application
Please apply online. For further information about the position, please contact your Gi Consultant, Mr. Nazim Sagkol (B. Eng.), (+41 76 349 85 07)
Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Industries
Medical Equipment Manufacturing and Biotechnology Research
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