Engineer/Process Supporter

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