Job Description:
Responsible for leading Pharma and Biopharma projects using DeltaV System or PLC Siemens with batch design (CM, EM, Phase, Recipe,..
Job Description:
Responsible for leading Pharma and Biopharma projects using DeltaV System or PLC Siemens with batch design (CM, EM, Phase, Recipe, etc)
Responsible for design & managing system integrator and ensure they follow company standards and approved guidelines
Responsible for managing internal stakeholders and coordination with various equipment owners to ensure their requirements are met in the PCS design and is implemented and tested in accordance with the company standards
Responsible for reviewing functional specifications and design specifications and ensuring these are aligned with project, global and local standards
Work with various teams to design system architecture, network architecture, cable schedule
Responsible for reviewing test documents and protocols (FAT, SAT, Interface Test, etc.) so that they meet CSV and QA standards
Responsible for participating in design meetings at various vendor locations
Responsible for witnessing 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
Support FAT, SAT, IQ, OQ and PQ
Job Requirement:
Minimum 10 to 15 years of Relevant Experience.
Expert 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.
Expert in ControlLogix Logic coding Languages - (ST, FBD, SFC, Ladder)
Database & Reporting - MS SQL Server, Crystal Report, and SSRS, VB & Excel based Report.
Familiar 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 Min 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
Hands on experience in IT application Infra Monitoring engineering tools - SevOne, Moogsoft, Dynatrace, Qualysys, MacAfee Trelix.
