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Danaher Corporation Enterprise Solution Process Design Engineer in Shanghai, China

Enterprise Solution Process Design Engineer

Shanghai, China

Be part of something altogether life-changing

Working at Cytiva in the Life Sciences industry 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.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

What you’ll do

The Process Design Engineer position reports to the Asia Process Design Manager, part of Life Sciences, CYTIVA.

Essential Responsibilities:

The Process Design Engineer will be responsible for providing competence and technical leadership in process, equipment and facility design related to biopharmaceutical manufacturing. The Process Design Engineer will lead the process design efforts to ensure optimal outcomes to support the customer application and manufacturing operation, in compliance with the applicable regulatory requirements. The Process Design Engineer will provide the necessary technical input to support/enable the design and development of biopharmaceutical manufacturing suite layouts, process equipment design, process equipment layout, clean utility requirements, and overall process engineering oversight required to ensure fit and function for the manufacturing technology application in alignment with customer needs and regulatory requirements.

Job Duties:

  • Support customer meetings by providing process understanding from pilot scale operation, technology transfer, large scale manufacturing and facility design experience. Develop, explore, and recommend manufacturing concepts to fit customer needs/facility requirements.

  • Provide Process Design & Engineering leadership to the Enterprise Project Team.

  • Work closely with the Enterprise Solutions Project Manager to support the Enterprise Solutions project specific design development, documentation, and execution in alignment with the project scope and schedule.

  • Work closely with Customer’s Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities in support of the project timeline.

  • Work closely with Engineering partner companies during Conceptual and Basic design development to ensure suitability, applicability and accuracy of Engineering partner designs, calculations, drawings; ensure they are in alignment with customer requirements.

  • Prepare design documentation and operational estimates such as Process Descriptions, Process Flow Diagrams (PFDs), Equipment Lists, Equipment and Automation URSs, Process Schedules, Production Planning, and utility usage estimates, Risk Assessments, Materials Balances, Cost of Goods Analysis, Cycle Time Analysis and Reduction, Uncertainty and Variability Analysis.

  • Work closely with FlexFactory Lead System Designers (LSDs) to ensure transfer of critical equipment requirement specification, that design meets customer and process needs, and that single-use equipment layout is optimized for the customer facility.

  • Provide design input, support and recommendations as needed with qualification test review and verification and during field execution, commissioning, and qualification testing.

  • Support design and construction discussions/issues between CYTIVA, Customer and EPCMV organization representatives

  • Oversee and coordinate facility design development

Quality Specific Goals:

Aware of and comply with the CYTIVA Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

Aware of and comply with the CYTIVA ES Project Management Manual, applicable laws and regulations as they apply to this job type/position

Complete all planned EHS & Compliance training within the defined deadlines

Identify and report any compliance concerns and take immediate corrective action as required

Who you are

BS or MS degree in biochemical / chemical engineering or a related engineering/life Science discipline Minimum of 3-5 years of relevant bioprocess experience. Experience in process development, tech transfer, scale-up and operation of biopharma facilities Experience in process modeling Knowledgeable in all aspects of upstream and downstream processes including batch, fed-batch and perfusion cultures; harvest/clarification; Chromatography and UF/DF operations Experience in clinical manufacturing of monoclonal antibodies and other biologics Thorough knowledge of biologics CMC, cGMP manufacturing requirements Disposable technology design and application experience Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.) Experience in working/leading within cross functional teams Fluent in English both verbally and in writing Comfortable in giving conference presentations and writing technical articles Experience in AutoCAD, Visio, MS Project SuperPro applications Detail oriented, excellent at critical analysis and problem solving Open to a changing environment Structured, organized, Analytical, Team oriented Expected to be out travelling 30-50% of the time.

When you join us, you’ll also be joining Danaher’s global organization, where 68,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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