As a senior eilectrical enginerr, you will responsible for create all requirements and related deliverables on the electrical and automation parts from the user point of view to guarantee the high quality and reliability of process equipments for solid dosage form production. You will assist the Project Manager to successfully plan and execute the projects in each project phases and reviews all critical design deliverables in the each project design and execution phases (PI, CD, BD, DD, installation & Commissioning and qualification), assist project from hand-over to Performance Qualification (PQ), Process Validation, operational start-up, and facility operation. Further responsibilities are:
•Responsible for project as a user
•Following GAMP, GEP, GMP and Roche standards
•Cooperate to Develop the User Requirements Specifications and all related deliverables
•Technical clarification on the quotation, sufficient electrical component spare parts list and all related HDS, SDS and wiring diagrams, pneumatic diagram, 21CFR part 11with the vendor
•Supervising execution equipment /System Installation, cabling , loop tests & commissioning(including system integration, configuration and testing) according to the GAMP, GEP and GMP
•Assist in facility maintenance and Support case studies and investigation on trouble shooting
•Support coordination with vendors and contractors
•Support establishing SOPs
You have Electrical & Automation Bachelor degree holder (equivalent) or above, have
Low voltage operation certificate. Other requirements are:
•Familiar with the professional documentation (HDS, SDS etc.) in English.
•Chinese, English on brief negotiation level.
•Basic SIMENS PLC programing and diagnosis on the I/O.
•Basic knowledge of AUTOCAD.
•Shows a high level of passion and engagement.
•Integrity,align for success,learn for the future,able to energize, engage and inspire others,Deliver results.
•Minimum 5 years’ working experience.
•Electrical engineering, Installation & commissioning, and project execution for Pharmaceutical Industry.
•High, low voltage distribution knowledge and maintenance experience.
•Familiar with PLC automation system and with basic instrument , sensor and IT knowledge.
•Must be familiar with GAMP5, 21 CFR Part 11 ERES, ATEX, ISO, EN, DIN, GB Code relevant to Electrical & Automation design and authority regulations.
•Electrical & Automation Knowledge in pharmaceutical solids manufacturing with high containment and WIP/CIP technology.
•Familiar with FDA, EMA and Chinese cGMP requirements.
•Electrical & automation knowledge regarding the design, operation, preventative maintenance of pharmaceutical manufacturing processes and equipment is required.
•Must have demonstrated ability to solve certain technical problems and ability to work independently.
•Must have excellent organizational, communication and writing skills

瑞士全球Top 5制药公司，化药工厂在上海张江，专注于肿瘤癌症等疾病领域。