DeltaV CSV Consultant - GMP/GxP Validation Expert

Advanced Manufacturing Tech Solutions (AMTSOL); Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

AMTSOL, a leader in life science manufacturing technology solutions, seeks a CSV Consultant with 3-6 years' experience to support GxP-compliant DeltaV systems in pharmaceutical manufacturing environments.

You will perform CSV activities across the system lifecycle (URS, IQ/OQ/PQ, traceability) and collaborate with Automation, Quality, and IT teams to ensure compliant delivery and lifecycle management.

Qualifications

• 3-6 years of hands-on experience in CSV within GxP-regulated environments.
• Fundamental understanding of Emerson DeltaV systems, including: control logic and configuration; batch concepts (ISA-88 awareness); user access, security roles, and audit trails.
• Experience with regulated system validation documentation and execution.
• Good understanding of 21 CFR Part 11, data integrity, and system security principles.
• Exposure to GMP pharmaceutical manufacturing operations.

Responsibilities

• Execute CSV activities across the system lifecycle (URS, RA, IQ, OQ, PQ, Traceability, Validation Reports).
• Support validation of DeltaV DCS systems, including configuration verification and functional testing.
• Review and verify control logic, batch configuration, and alarm management from a CSV perspective.
• Validate user access management, roles, security settings, and login controls in DeltaV.
• Support change control, deviation handling, and impact assessments for system updates.
• Participate in risk-based validation aligned with GAMP 5 and site CSV standards.
• Collaborate with Automation and Quality teams during testing, execution, and audits.
• Support regulatory inspections and internal audits as required.

Skills

CSV (GxP) experience

Regulatory compliance

GAMP 5 awareness

Education

Bachelor's degree in Engineering, Computer Science, or a related technical discipline

Tools

DeltaV

Job description

AMTSOL, a leader in life science manufacturing technology solutions, seeks a CSV Consultant with 3-6 years' experience to support GxP-compliant DeltaV systems in pharmaceutical manufacturing environments.

You will perform CSV activities across the system lifecycle (URS, IQ/OQ/PQ, traceability) and collaborate with Automation, Quality, and IT teams to ensure compliant delivery and lifecycle management.