DeltaV CSV Validation Engineer - Pharma GMP

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, 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.