Enterprise Solutions Lead Process Engineer

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 Lead the development of a new CT process design offering. Work with internal stakeholders to develop and optimize key deliverables templates to meet the CT customer's process needs. Responsible for providing competence and technical leadership in process, equipment and facility design related to cell and gene therapy manufacturing. Experience in process modeling Work with the ES Leader, Product Managers, OpCos to identify new offerings to expand the CT FlexFactory solution. Work with the ES proposal team to setup a new tool for the BDMs to review with the Customers to better define the CT FlexFactory Scope Responsible for the CT FlexFactory system design which includes but not limited to the generation of relevant design documents including Process Flow Diagrams (PFDs), equipment lists, utility requirements, process descriptions, user requirements specification (URS), general specification (GS), equipment configurations and design approval packages for the FlexFactory components. Support the system design process from requirements development and design planning to final design approval by customer. Work with the project team to ensure applicable customer requirements specification (URS) can be met by the FlexFactory design, and ultimately fulfilled by the end product. Support a cross-functional team of engineers, Process Design Engineers and customer. Support detailed design and solve any design issues during the design phase and acts as a point of contact for system design related questions. Participates in developing and updating the FlexFactory project schedule. Coordinates with the Product Manager SPOC who will Initiate the FlexFactory equipment product code registration. Support customer meetings by providing system hardware understanding Work closely with Customer's Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities on time Work closely with Process Design Engineers to ensure that the equipment specification meets customer and process needs, and that equipment layout is optimized for the customer facility. Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Final Design Reviews(FDRs) and New Product Introduction(NPI) program milestones. Support continuous improvement activities by driving the implementation of process and product quality improvement initiatives Complete all planned Quality & Compliance training within defined deadlines Identify and report any quality or 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 10years of relevant bioprocess/Cell Therapy industry experience. Min 5years of direct experience working in a pilot plant or GMP manufacturing facility experience." Possess working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use technology. Knowledge of biologics CMC, cGMP manufacturing requirements. Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.). Experience in working/leading with cross functional teams. Experience with Visio, MS Project, SuperPro. Results orientated, highly driven, self-motivated with the determination to succeed within a fast-paced and very sophisticated environment. Comfortable working in global business environment. Structured, Organized, Analytical. Fluent in English both verbally and in writing. Comfortable in giving conference presentations and writing technical articles. Fluent in Mandarin verbally and written is a plus. Approximately 30-50% travel depending on project specifics and geographic location 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 wi