As a first-tier supplier to our renowned business partner, Roche Diagnostics in Rotkreuz, we are immediately seeking a motivated and dedicated Process Supporter for a temporary assignment of one year with the possibility of extension
The Department Design Control Excellence 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
- Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration Management and/or Verification & Validation Management
- 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 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
Benefits
- Work with modern and modern tools in an innovative working environment
- Experience a work culture that promotes diversity and inclusion and in which all employees feel valued
- Profit from financial support for your professional further training plans
- Take advantage of unbeatable discounts at renowned retailers and over 200 top brands all year round
- Profit from fleet discounts when purchasing new cars or receive constant discounts on fuel with our fuel card
Are you interested? Do not hesitate and submit your complete application documents online today. We look forward to hearing from you!
Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.
