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Automation Specialist
2 months ago
CUTE SOLUTIONS & SERVICES PTE. LTD. is seeking a highly skilled Automation Specialist to lead Pharma and Biopharma projects using DeltaV System or PLC Siemens with batch design. The ideal candidate will have expertise in Development Tools, Industrial Protocols, and ControlLogix Logic coding Languages.
Key Responsibilities- Lead Pharma and Biopharma projects using DeltaV System or PLC Siemens with batch design.
- Design and manage system integrator to ensure they follow company standards and approved guidelines.
- Manage internal stakeholders and coordinate with various equipment owners to ensure their requirements are met in the PCS design.
- Review functional specifications and design specifications to ensure alignment with project, global, and local standards.
- Work with various teams to design system architecture, network architecture, and cable schedule.
- Review test documents and protocols to ensure they meet CSV and QA standards.
- Participate in design meetings at various vendor locations.
- Witness FAT's and interface test at various vendor locations.
- Work closely with qualification teams to support qualification test generation and execution efforts in IQ, OQ, and PQ.
- Minimum 10 to 15 years of relevant experience.
- Expertise in Development Tools - RSLogix5, RSLogix500, RSLogix5000, Studio5000, RSLinx.
- Experience in Industrial Protocols - Modbus, Modbus TCP, HART, Ethernet IP, OPC UA, OPC DA, ControlNet, Device Net, Industrial control protocols such as RS232/485.
- Expertise in ControlLogix Logic coding Languages - (ST, FBD, SFC, Ladder).
- Database & Reporting - MS SQL Server, Crystal Report, and SSRS.
- SCADA - FactoryTalk View & Historian, Siemens WinCC, Ifix, Wonderware, Iconics, Schneider.
- Familiarity with Industrial Protocols - Modbus, Modbus TCP, HART, Ethernet IP, OPC UA, OPC DA, ControlNet, Device Net, Industrial control protocols such as RS232/485, CAN/Open, Modbus RTU, traditional IO (4-20 mA, etc), Foundation Fieldbus, etc.
- Computer System Validation (CSV) 21CFR part11 (GAMP-5) using GMP & CGMP automation process industries.
- Good knowledge and minimum 5 years' experience in regulatory audits (US-FDA, MHRA, EU-GMP).
- Knowledge in Industrial Cybersecurity ISA IEC 62443 Standards.
- Experience on Automation Compliance projects Familiar with process controls equipment. Strong knowledge of Computerized Systems, Compliance regulations, and standards.