Execute the CSV lifecycle for PLC and SCADA systems, including risk assessments, specification review, traceability, IQ, OQ, PQ, regression testing, and validation reporting.
Qualify hardware infrastructure including PLCs, I/O systems, HMI terminals, SCADA servers and workstations, industrial networks, managed switches, and virtualized environments.
Validate PLC software and control logic, including Ladder Logic, Function Block Diagrams, Structured Text, Sequential Function Charts, alarms, interlocks, sequences, and recipes.
Validate SCADA applications including HMI graphics, alarm management, historian functionality, audit trails, security, electronic signatures, data collection, reporting, and system interfaces.
Support FAT, SAT, commissioning, qualification, system handover, and approved changes.
Verify data-integrity and compliance controls, including user-account management, security roles, electronic signatures, backup/restore, and time synchronization.
Support industrial cybersecurity, system hardening, and validated infrastructure controls where applicable.
Support integration and interface testing with MES, OSI PI/AVEVA PI historian, ERP, DCS, and package-equipment systems.
Manage deviations, change controls, test discrepancies, vendor evidence, and validation documentation through closure.
Coordinate with Automation, CQV, Quality, IT/OT, Manufacturing, vendors, and system-integrator teams
Minimum 5 years of PLC/SCADA CSV experience within pharmaceutical, biotechnology, medical-device, or another GMP-regulated environment.
Proven experience qualifying automation hardware and validating PLC code and SCADA applications.
Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, GMP data-integrity requirements, and validation lifecycle documentation.
Experience with one or more PLC platforms such as Siemens, Allen-Bradley/Rockwell, Schneider, or Mitsubishi.
Experience with SCADA platforms such as WinCC, FactoryTalk, AVEVA/Wonderware, Ignition, or iFIX.
Working knowledge of industrial communications such as OPC, Profinet, Profibus, Modbus TCP/IP, or EtherNet/IP
