ITech Consult
Zug, Zug
30/04/2024
Project-based
Engineer (Process Supporter) - Process management/ GMP /diagnostic/Database/German Project: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Engineer (Process Supporter) Background: The Department Process Support CH 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. 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, Verification and Validation Management, and/or Usability Engineering . Support translation of multi-level requirements via Requirements Management process . Conduct detailed risk assessments by analysing 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 their 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 Reference Nr.: 923407TP Role: Engineer (Process Supporter) Industrie: Pharma Workplace: Rotkreuz Pensum: 80 - 100% Start: 01.06.2024 Duration: 12 Deadline : 06.05.2024 If you are interested in this position, please send us your complete dossier via the link in this advertisement. About us : ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering. We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.