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.
