SHDM IVD Sr. Engineer, Facilities-BU/CU 厂务工程师（公用/洁净工程）
If you are ambitious and change makes you thrive, help transform Siemens Healthineers into a learning organization.
o The sr. engineer in the Facilities Engineering Group will develop requirements for Facilities equipment, justify capital equipment expenditures, and deliver validated equipment to the Shanghai site to meet existing and forecasted operational needs. The sr. engineer will maintain lead responsibility for major capital projects from inception through introduction to production and beyond.
o This sr. engineer will also identify and implement process improvements and cost reductions to achieve continuous improvement goals. The engineer will conduct detailed capacity analyses and define needs related to acquiring new equipment and processes in support of expanding site requirements.
o This individual will confirm performance by designing and conducting tests, including detailed work instructions and validation protocols. Job scope expands beyond the mechanical equipment focus and will encompass manufacturing operations.
o This individual will have project leadership responsibilities and will be expected to mentor junior staff members within the engineering department. The candidate will also participate in development of departmental methods intended to ensure business objectives will be met.
• AREAS OF RESPONSIBILTIES:
o Completes complex material specification, schematic preparation and follow-up to ensure proper and effective implementation.
o Performs complex design, development, testing and modification of solutions.
o Performs explanations and clarifies information to enable proper interpretation and evaluation of complex specifications, performance characteristics or other technical data.
o Performs communication of complex technical and commercial issues. Completes recommendations for complex new designs, new processes or design changes to meet requirements.
o Responsible for assigned system operation, mainatenance, qualification routine tasks, and deviation and change control handling.
o Approximately 20% international travel.
This position may suit you best, if building learning organizations is your expertise and you have extensive experience with Top Management Learning and Leadership Development.
o BS/BA in related discipline, or advanced degrees, where required, or equivalent combination of education and experience.
o Advanced degrees may be substituted for experience, where applicable.
o 5~8 years related working experience.
o Experience working in a medical diagnostic or similar regulated environment is desirable.
• REQUIRED SKILLS:
o Must have demonstrated ability in Black utilities (chilly water ,hot/cold water, WWPT, etc) Clean utilities systems. (CDA, N2, compressed air, Inert gas, purified water, etc.)
o Must be familiar with risk/ requirements analysis, design skills, safety management, CAD and the function of complex manufacturing operations.
o Ability to combine hands-on experience with engineering theory is critical.
o Must be able to read and interpret mechanical electrical, plumbing design drawings (MEP’s).
o Must have demonstrated ability to compose technical documentation including detailed work instructions and validation protocols.
o Generate, modify, and verify cGMP documentation: Standard Operating Procedures (SOP), Preventative Maintenance Plans, Corrective and Preventive Action (CAPA), and Change Control Requests (CCRs).
起草，修改以及核实cGMP支持文件：标准操作流程SOP, 预防维护计划PM, 纠正及预防措施CAPA, CCRs
o Author, modify, and verify facility related project documentation: User Requirement Specifications, Piping and Instrumentation Diagrams, Instrument Specifications, Installation and Operational Qualifications
起草，修改以及核实厂务相关的项目文件：用户需求URS, 流程图PID, 仪表规格，安装验证 IQ, 运行验证 OQ等.
o Must have demonstrated the ability to successfully manage complex technical projects and lead cross functional teams.
o The successful candidate will have demonstrated effective formal written and oral communication skills.
o The candidate must have demonstrated ability to make formal presentations to site management.
Job ID: 76440
Organisation: Siemens Healthineers
Experience Level: Mid-level Professional
Job Type: Full-time