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.