Engineer - DeltaV

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

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

You will lead validation lifecycle activities, generate URS/FS/DS, qualify hardware and software, support FAT/SAT, and ensure data integrity, security and regulatory compliance across interfaces with MES and historians.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• Minimum 5 years DeltaV CSV experience in GxP environments.
• Experience qualifying DeltaV hardware and validating software modules.
• Knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity.

Responsibilities

• Plan and execute the DeltaV validation lifecycle from strategy to reporting.
• Author and review URS, FS, DS, risk assessments, and traceability matrices.
• Qualify hardware and software, including DCS modules and I/O systems.
• Support FAT, SAT, commissioning, and system handover activities.
• Ensure data integrity, audit trails, and electronic signatures compliance.
• Coordinate with CQV, IT/OT, QA, and system integrators.

Skills

DeltaV CSV

Validation lifecycle

GxP compliance

Technical writing

IQ/OQ/PQ

Risk assessment

Regulatory documentation

Education

Bachelor’s degree in Engineering / related field

Tools

Kneat

OSI PI

PI Historian

Job description

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.