AMTSOL is supporting a pharmaceutical manufacturing project in Singapore and is seeking a DeltaV CSV Engineer to plan execute and document validation activities for Emerson DeltaV systems in accordance with GxP GAMP 5 21 CFR Part 11 EU Annex 11 and site quality requirements.

Key Responsibilities

• Plan and execute the DeltaV validation lifecycle including validation strategy risk assessment requirements and design review traceability IQ OQ PQ regression testing and validation reporting.
• Author and review validation deliverables such as URS FS DS risk assessments traceability matrices test protocols discrepancy records and validation summary reports.
• Qualify DeltaV hardware and infrastructure including ProfessionalPLUS Application and Operator Stations M-Series/S-Series/PK controllers CIOCs I/O systems network components servers and virtualized environments.
• Validate DeltaV software configuration and application functionality including Control Modules Equipment Modules Unit Modules batch phases recipes alarms interlocks graphics interfaces and security settings.
• Support design reviews FAT SAT commissioning qualification system handover and approved change implementation.
• Verify data-integrity and compliance controls including audit trails user-account management security roles electronic signatures backup/restore and time synchronization.
• Support cybersecurity and system-hardening activities for validated DeltaV environments.
• Support validation of interfaces with MES OSI PI/AVEVA PI historian and other manufacturing systems where applicable.
• Manage deviations change controls test discrepancies vendor evidence and validation documentation through closure.
• Coordinate closely with Automation CQV Quality IT/OT Manufacturing and system-integrator teams.

Requirements

• Bachelors degree in Engineering Automation Instrumentation Computer Science Pharmaceutical Technology or a related technical discipline.
• Minimum 5 years of DeltaV CSV experience in pharmaceutical biotechnology or another GxP-regulated environment.
• Proven experience qualifying DeltaV hardware infrastructure and validating DeltaV software modules and batch applications.
• Strong working knowledge of GAMP 5 FDA 21 CFR Part 11 EU Annex 11 GMP data-integrity requirements and validation lifecycle documentation.
• Strong technical writing test execution discrepancy management and stakeholder-coordination skills.

Preferred / Advantageous

• CSV experience with PLC/HMI or SCADA platforms such as Siemens SIMATIC WinCC or SIMATIC Logon.
• Experience using electronic validation platforms such as Kneat.
• Exposure to system integration industrial cybersecurity virtual infrastructure or OT network qualification.