Position: CSV/Automation Engineer
Responsibilities

5 to 10 years of experience in multinational pharma/biopharma companies with hands on experience in Process automation engineering
Experience in designing and implementation / testing / commissioning / Qualification of (DCS/PLC/SCADA/BMS/EMS systems)
Experience in trouble shooting for automation and control systems
Drive and Lead Automation (DCS/PLC/SCADA/BMS) Projects
Technical understanding and experience in of automation platforms, such as Delta V, Honeywell, Rockwell PLC, Siemens XFP
Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation
Support to change controls, investigations, deviations, and CAPAs
Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results
Working closely with the systems integrators, automation leads & process leads
Completing the FAT, SATs, IQ, OQ. creating and executing the protocols & documentation
Knowledge of E2500, V Model concepts along with GAMP5, S88, S95
Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments
Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills
Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus
Ability to travel up to 50% or more within and outside Malaysia
Large scale project experience
Valid Passport with no restrictions to travel

Education

Engineering degree in Automation, Instrumentation, EEE, ECE

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CSV/Automation Engineer

Job Description

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