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
- Bachelor’s 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.
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