CSV/Automation Engineer

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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