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

• Bachelors 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.