CSV/Automation Engineer
2 weeks ago
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, SAT's, 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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