AMTSOL is supporting a pharmaceutical manufacturing project in Singapore and is seeking a PLC/SCADA CSV Engineer to validate and qualify automation hardware, software, and system interfaces in compliance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and GMP data-integrity requirements.

Key Responsibilities

• 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.

Requirements

• Bachelor’s degree in Engineering, Automation, Electrical Engineering, Computer Science, or a related discipline.
• 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.

Preferred / Advantageous

• Experience in GMP manufacturing, utilities, packaging, or process-automation systems.
• CQV or commissioning experience and exposure to industrial cybersecurity/system hardening.
• Knowledge of DeltaV qualification or CSV activities.
• Experience using electronic validation platforms such as Kneat.