(CSV) Engineer - DeltaV

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

Job summary

AMTSOL is seeking a DeltaV CSV Engineer to plan, execute, and document validation activities for DeltaV systems in Singapore, ensuring compliance with GxP, GAMP 5, 21 CFR Part 11 and EU Annex 11. The role demands collaboration with CQV, IT/OT, and manufacturing teams across the site.

The successful candidate will qualify DeltaV hardware and software, author validation deliverables, manage deviations and change controls, and ensure data integrity and security across validated environments.

Qualifications

• Minimum 5 years of DeltaV CSV experience in pharmaceutical/GxP environments.
• Strong knowledge of validation lifecycle documentation and regulatory requirements.

Responsibilities

• Plan and execute the DeltaV validation lifecycle from strategy to reporting.
• Author and review URS, FS, DS, risk assessments, traceability matrices, test protocols and validation reports.
• Qualify DeltaV hardware and software components including controllers and IO systems.
• Validate Control Modules, Unit Modules, batch applications and graphics.
• Support FAT, SAT, commissioning, qualification and system handover.
• Verify data integrity, audit trails, electronic signatures, and security controls.
• Coordinate with Automation, CQV, Quality, IT/OT, Manufacturing and system integrators.

Skills

GxP compliance

CSV validation

Documentation

Stakeholder coordination

GAMP5

Technical writing

Test execution

Change control

Education

Bachelor’s degree in Engineering

Tools

DeltaV

Kneat

OSI PI

SCADA

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.