药明生物
Automation DCS Engineer (Application Focus)
岗位职责
KEY ACCOUNTIBILITIES: · Responsible for deployment and verification of customized new functionalities in the automation DCS system. · Prepare installation manuals and validation documentation for functional deployments. · Perform commissioning of automation and control systems, and support validation teams in system
任职要求
. · Manage completion, handover, and acceptance of automation systems and related equipment. · Support testing and troubleshooting during system functionality development. · Assist production teams in achieving digitalized processing, including automatic data acquisition, analysis, and modeling. · Support regulatory inspections and audits related to automation and electronic systems. · Perform daily operation and maintenance of existing control systems. · Complete other tasks assigned by the supervisor. REQUIREMENTS: · Experience in DeltaV software/hardware functional design, commissioning, and system operation & maintenance. · Experience in design, commissioning, or operation & maintenance of automation equipment and systems in the biopharmaceutical industry. · Familiarity with end-to-end biopharmaceutical manufacturing processes (e.g., cell culture, purification, formulation) and related automated control workflows, as well as GMP regulatory requirements (preferred). · Experience with mainstream bioprocess automation control systems such as Thermo Fisher TruBio or Cytiva (GE) ÄKTA Unicorn is preferred. · Experience with DCS digital twin simulation is a plus. · Familiarity with GMP, FDA 21 CFR Part 11, EU GMP Annex 11 requirements, and system validation processes (IQ/OQ/PQ) is preferred. · Good English speaking, reading, and writing skills for daily technical communication, meetings, and documentation. · Strong attention to detail, logical thinking, execution capability, and planning skills; able to objectively analyze and solve problems. · Strong communication and coordination skills; able to collaborate effectively with internal and external teams.
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