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 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 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. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

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.