Process Supporter

vor 3 Monaten

Rotkreuz, 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 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%
**Duration**:12++

**Job Type**: 80-100%

Schedule:

- 8 Hour Shift

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