Process Supporter

vor 1 Woche


Rotkreuz, Zug, Schweiz ITech Consult Vollzeit

Engineer (Process Supporter)

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.

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 multilevel 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 teamplayer

Reference Nr
:

923407TP

Role:

Engineer (Process Supporter)
Industrie:

Pharma

Workplace:

Rotkreuz

Pensum:
80
-100%

Duration:
12++

Job Type:
80-100%

Schedule:

  • 8 Hour Shift


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