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.
The Lead Process Engineer for Cytiva is responsible for:
•Analyze customer process user requirements specification for Cytiva equipment used in the Biopharmaceutical industry, which will focus on downstream system.
•As technical lead of a project team 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 to specification, on time and within budget.
•Take ownership of very complex technical tasks and issues.
•Manage and co-ordinate small to large-size projects
•It will be preferred that the candidate has systems engineering competence within the automation & electrical area and can advise vendors & customers on automation potential in manufacturing and assembly systems.
•It will be also preferred that the candidate support validation tests in accordance with test requests, specifications, have good knowledge of system manufacturer’s specifications and GMP validation standard for biotech devices.
This position is part of the Custom Engineering, BioProcess China, located in Shanghai, China and will be on-site. 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 (Time Spent 30 %)
•Analyze Customer User Requirements specifications
•Define technical solutions including analysis of process mass balance, 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 costs
•Request, analyze and implement quotations for all main sub suppliers and include in technical proposal
•Develop Project schedules
•Perform Project Risk assessments
•Present and discuss technical solution with customer
Project Execution (Time Spent 60 %)
•Contract review following customer order
•Magic project creation and maintenance
•Develop Project Quality Plan
•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
•Coordination of incoming goods inspection
•Assessing and resolving complex technical/process issues
•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.
•Project Management and co-ordination of Small and mid-size projects.
•On the job training for new team members
•Drive and Participate in Continuous improvement processes
•Chair/Execute daily visual management
General Administration (Time Spent 10 %)
The essential requirements of the job include:
Basic Qualifications:
•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 downstream systems.
•Minimum 7 years of experience in the design and engineering of process equipment Chrom, IC, PUPSIT and Bulk filling, filtration, separation and purification equipment
(Single use technology, direct or tangential flow, filtration etc.) used in a upstream & downstream process.
•It will be preferred having 3 years of experience in PLC design or electrical design
•It will be preferred having 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.
•It will be preferred experience of working with outside sub-contractors including mechanical fabricators, electronic fabricators, Software designers and automation experts.
•It will be preferred experience in qualification activities (FAT/SAT) for process equipment in the biopharmaceutical industry.
Position Competencies (include behavioral characteristics and leadership capabilities)
•Ability and willingness to work in a multinational and interdisciplinary team with necessary travelling.
•Proven experience and success working cross functionally with Commercial (Account Managers, Specialists, Regional Managers) technical teams, Marketing, Product Management and Senior Managers.
•Fluent Language skills in English.
•Knowledge and understanding of the current industry guidelines for designing, manufacturing, testing and documenting biopharmaceutical process equipment. (ASME BPE, GAMP, cGMP, ISPE, cFDA etc.)
•Ability to teach other team members from professional experience and detailed technical knowhow.
Other Requirements (include culture, fit and values)
•To work safely and to comply with the company’s health, safety and environmental (HSE) policies and procedures.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.