DeltaV CSV Engineer — Validation Lead for GxP Systems

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 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.