For our client, a leading pharmaceutical company in Switzerland, we are looking for an Engineer/Process Supporter.
General Information:
- Start date: 01.07.2025
- Latest possible start date: 02.08.2025
- Duration: 1 year, with the possibility of extension
- Workplace: Rotkreuz
- Workload: 100%
- 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