The Process Engineer for Cytiva is responsible for the Single Use Customized hardware project and consumables designing. Including single use mixing and storage system, single use bulk filling system and single use filtration system and so on.
Being the technical lead of a project team to discusses, propose, define final technical system solution with the customer including writing technical part of quotation and associated costing. After Order placement execute the proposed engineered system solution based on agreed and defined contractual specification together with a defined project team as project manager or process engineer. Make sure the projects are delivered in accordance with specification, on time and within budget.
This position is part of the Customer Engineering located in Shanghai. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
In this role, you will have the opportunity to: · Pre order Activities - Analyze Customer User Requirements specifications. - Communication with customer about SUT consumables and finish drawing of SUT consumables for upstream & downstream applications, including single use mixing bags/storage bags/filtration manifolds/final filling manifolds/transfer sets… - Define technical solutions including equipment selection and sizing, drafting process and instrumentation diagrams. - Write technical proposals including clarification and exclusion lists. - Create Project Costing sheets including material and manpower cost . - Request, analyze and implement quotations for all main sub suppliers and include in technical proposal . - Present and discuss technical solution with customer .
· Project Execution - Complete basic design including process and instrumentation diagram, component lists and process functional specifications - Obtain valid quotations for all materials and initiate orders with procurement. - Cross functional communication, progress monitoring, co-ordination of sub supplier activities (e. g. mechanical fabricators, electrical fabricators and software companies). - Progress monitoring, reporting and control - Financial status monitoring, reporting and control - Assessing and resolving complex technical/process issues - Execution and coordination of Qualification/Verification activities at the various project stages (pre-FAT, FAT, SAT, IV/OV) - Creation of technical documents and co-operate with Documentation team to assemble final technical documentation package. - Drive and Participate in Continuous improvement processes
· New Technology Innovation - Drive and Participate in Continuous Technology improvement processes
The essential requirements of the job include: · BSc/MSc or equivalent in Biochemical engineering, Process engineering, chemical engineering or equivalent. A higher degree or secondary degree in a related subject would be an advantage · Adequate industry knowledge on biopharmaceutical processes, technologies, products and their applications and in-depth knowledge and experience on hardware used in pharmaceutical GMP factories. · 1-3 years of experience in the design and engineering of process equipment for bioreactor, filtration, separation and purification equipment (Single use technology, direct or tangential flow, filtration etc.) used in a upstream & downstream process.
It would be a plus if you also possess previous experience in: · It will be preferred having 1-3 years of concept, knowledge and experience in system · Hardware validation work in which confirm what the team have designed and · Manufactured for the customer. · Experience in qualification activities (FAT/SAT) for process equipment in the · Biopharmaceutical industry.
Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.