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For our client, a leading pharmaceutical company in Switzerland, we are looking for an Engineer/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
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Contract
Job function
* Job function
Other
* Industries
Pharmaceutical Manufacturing
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