Who we are:
At Roche, 90,000 people across 150 countries are pushing back the frontiers of healthcare. Working together. Our success is built on innovation, curiosity and diversity.
As the worldwide market leader in in-vitro diagnostics, Roche is committed to providing the latest cutting-edge diagnostic solutions to advance the health and wellness of people worldwide. Roche Diagnostics (Suzhou) Ltd. was established in April 2015, with approximate investment of 450 million CHF and went into operation in end of 2018.
The new manufacturing site with a R&D center in Suzhou, China, addresses the growing demand for diagnostic tests in China and the Asia Pacific region; ensuring people have access to high-quality reagents, while providing a long-term sustainable contribution to meet the healthcare needs of the region.
Who you are:
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies.
Where a job title is not considered the final definition of who you are, but the starting point.
What we expect you could, as each colleague around you, aim high and think out of the box, embrace new changes and things with open mind. Confront challenges with passion and courage. Work with colleagues with integrity and keep up the good job.
The job holder takes responsibility for leading projects within manufacturing, including certain CAPEX projects, continuous improvement and lean projects, as required....
The job holder also leads performance monitoring across all manufacturing areas, supporting the area/equipment owners in the update of standard manufacturing costs system parameters (SAP).
Main Tasks & Responsibilities主要工作职责:
Contact person with site engineering for manufacturing area, includes requirements collection/budgeting
Support manufacturing team to establish and maintain CAPEX management processes, ensuring each project is compliant with regulatory, Roche global and RDSZ standards.
Responsible to manage individual improvement/CAPEX projects, develop project management system and platform, including documentation management, meeting management, training coordination, objective/milestone management, which includes but not limited to:
Project planning & execution, working with cross functional stakeholders to deliver high quality project management, including risk, time, cost and quality management.
Lessons-learnt for projects and user satisfaction feedback etc...
As a contact window with Roche Global Engineering for individual projects when task assigned accordingly
Participate in the design and implementation of new equipment according to divisional and local standards.
Identify any opportunities to improve the production processes from an Industrial engineering perspective
Find opportunities for OEE improvement etc. And initiate /mange the improvement project with the corresponding production owners.
As contact window for lean program, as leading project driver for lean activities within manufacturing.
Manage all the layout/drawings for manufacturing area, work with site engineering for update and manage the production area equipment layout and drawing of people/material flow.
Packaging engineering support, includes material testing, primary packaging material localization etc.
Ensuring all the responsible projects with manufacturing are fully compliant with corporate directives and local laws/regulations where appropriate.
As a site SME/Consultant, take responsibility for training and technical transfer to operation/maintenance team for involved new project.
Other tasks assigned by Head of Department.
Qualification Required 资质要求：
Bachelor's Degree, with a major in Industrial, Mechanical or Electrical engineering
Preferably a PMP holder
> 6 years working experience in a highly regulated manufacturing environment
Project management skills, more than 3 years working experience in Project Management
Rich experience on new production equipment Q&V, Good understanding of the commissioning and qualification e.g. SAT/FAT/IQ/OQ/PQ process and activities
Equipment management experience
Familiar with problem solving methods
Experience in a highly regulated cGMP manufacturing environment
Knowledge in SAP system
Familiar with mechanical and electrical principles, understanding of hardware and software design
Ability to convey concepts and report to different management levels and across functions within the organization
Project management skills. Good understanding of the commissioning and qualification process and activities
Knowledge of electrical and mechanical local and overseas requirements and standards (e.g. CE / CCC)
Rich experiences in risk assessments such as PFMEA methodology.
Proficient knowledge of Mandarin and English (written & spoken)
Knowledge AutoCAD and OEE measurement/improvement