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.
Main Tasks & Responsibilities:
- Function and role of this position consists of the following parts but not limited to:
- Own and manage site facilities/utilities capital project implementation through overall lifecycle of project management, includes site master planning, define project requirements, feasibility study, project application, engineering, procurement, construction and installation, commissioning and qualification, validation and handover.
- Drive SHE performance and culture within project implementation process to proactively identify risks, eliminate issues, prevent injuries/exposure, and secure our site permits (fire, insurance, etc).
- Drive GMP/Compliance performance and culture within Site Services to meet all Quality/Regulatory requirements to support lot release and secure our GMP License
- Manage effective communication with all relevant stakeholders.
- Takes ownership for problem resolution and escalates as appropriate.
- Responsible for analysis, design, cost estimates, and schedules follow for modification project or new project.
- As Project Manager, monitor, direct and control activities of engineering consultants and construction contractors.
- Lead developing of User requirement specification, Arrange design reviews, recommendation and coordination.
- Assist in development and implement site master plan at area of automation.
- Provide overall project control to adhere to budgets, scope and schedule.
- Manage multiple projects at various stages of planning, design, procurement and construction.
- Bachelor or above education background, Major in M & E engineering, environmental engineering, chemistry engineering or automation related.
- 5 years of GMP Plant project engineering experience with design / installation / qualification / acceptance / handover and also 0020 related laws & regulations approach to different standards, e.g. ISO13485 and GMP
- HVAC, cold room and clean room qualification and validation experience is preferred.
- Cleaning, cleaning system(CIP/SIP technologies) and cleaning validation
- Proven communication skill in cross function department and external relationship
- Proven ability to manage the assets and relevant operations
- Fluent language skills in English and Mandarin
- By practicing in Engineering in international companies