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Engineer/process supporter

Rotkreuz
Randstad
Prozessingenieur
Inserat online seit: 10 Juni
Beschreibung

JobdescriptionFor our client, a leading pharmaceutical company in Switzerland, we are looking for an Engineer/Process Supporter. General Information: Start date: 01.07.2025Latest possible start date: 02.08.2025Duration: 1 year, with the possibility of extensionWorkplace: RotkreuzWorkload: 100%Remote/home office: max. 40%, after onboardingTeam: 6 peopleDepartment: Design Control Excellence CH (DSRSPC)Working hours: StandardAbout 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 ManagementSupport translation of multi-level requirements via Requirements Management processConduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representativesEnsure all risks and requirements are maintained within a database and streamline approach across projectsEnsure the delivery of timely and good quality risk and requirements documentationEstablish and perform Configuration Management in complex development projectsSupport 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 informationIndependent execution of work packages within area of responsibilityOrganize and manage own time within scope of assigned work packagesEnsure the delivery of timely and good quality documentation Must Haves: University degree in Life Sciences, Natural Sciences or EngineeringFirst experience and good technical understanding of product development processes within a highly regulated environmentDatabase experience preferredExperience in Process Management (Risk-, Requirements-, Configuration-, Defect and/or Verification Management) is a plusExperience in the Diagnostics industry and experience within the GMP regulated environment is a plusGood analytical thinking, a structured, reliable working manner, ability to prioritize, plan and manage multiple tasks and to instill a sense of urgency in teamsAbility 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 goalsExcellent verbal and written communication skills in English, and preferably German in additionExcellent communication and presentation skillsOpen 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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