For our client, a leading pharmaceutical company in Switzerland, we are looking for anEngineer / Process Supporter.
General Information :
* Duration : 1 year, with the possibility of extension
* Remote / home office : max. 40%, after onboarding
* Team : 6 people
* Department : Design Control Excellence CH (DSRSPC)
* Working hours : Standard
About the work :
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.
Your Profile :
The “perfect candidate” has a university degree in Life Sciences, Natural Sciences or Engineering as well as first experience and good technical understanding of product development processes within a highly regulated environment (working experience or internship). Database experience and experience in Process Management is of advantage. Experience in the Diagnostics industry and experience within the GMP regulated environment is a plus.
Tasks & Responsibilities :
* 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
Must Haves :
* University degree in Life Sciences, Natural Sciences or Engineering
* First experience and good technical understanding of product development processes within a highly regulated environment
* Database experience preferred
* 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
* Good analytical thinking, a structured, reliable working manner, ability to prioritize, plan and manage multiple tasks and to instill a sense of urgency in teams
* Ability to lead by influence, demonstrated effectiveness, drive decisions and account for results; ability to resolve conflicts and adapt to change, effective to drive results and achieve project goals
* Excellent verbal and written communication skills in English, and preferably German in addition
* Excellent communication and presentation skills
* Open minded team-player
Sounds interesting?Apply now– we’re looking forward to receiving your applications!
Application Submission Deadline : 12.06.2025
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