DeltaV CSV Engineer: GMP System Validation & Compliance

Coalesce Management Consulting; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Coalesce Management Consulting seeks a Computer System Validation (CSV) Engineer with hands-on Emerson DeltaV experience to support validation of automated systems in a regulated manufacturing environment in Singapore. You will develop and execute CSV documentation, manage lifecycle activities, coordinate with QA, IT, and manufacturing, and ensure compliance with GMP, data integrity, and GxP standards.

This role requires 3–4 years DeltaV experience, a relevant engineering degree, and a

Qualifications

• Requires Bachelor's degree in a relevant field.
• 3–4 years of CSV experience in regulated environments.
• Hands-on DeltaV experience.
• Solid grasp of lifecycle validation principles.

Responsibilities

• Develop, review and execute CSV documentation for DeltaV and GMP systems.
• Prepare validation deliverables: URS, FDS, OQ/PQ, IQ, risk assessments, validation plans.
• Perform risk-based validation across system lifecycle.
• Validate DeltaV DCS configurations, recipes and batch processes.
• Review configuration and docs to GMP alignment.
• Execute validation test scripts: functional, security, audit trails, data integrity.
• Investigate deviations and CAPA; document resolutions.
• Support change control and validation impact assessments.
• Support periodic reviews, retirement and lifecycle docs.
• Collaborate with Automation, IT, QA, Manufacturing and vendors.
• Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11 and data integrity.
• Support regulatory inspections and audits as needed.

Skills

CSV validation expertise

GMP compliance understanding

Risk-based validation

Cross-functional teamwork

Education

Bachelor's degree in Engineering/related field

Tools

Emerson DeltaV

DeltaV DCS

Job description

Coalesce Management Consulting seeks a Computer System Validation (CSV) Engineer with hands-on Emerson DeltaV experience to support validation of automated systems in a regulated manufacturing environment in Singapore. You will develop and execute CSV documentation, manage lifecycle activities, coordinate with QA, IT, and manufacturing, and ensure compliance with GMP, data integrity, and GxP standards.

This role requires 3–4 years DeltaV experience, a relevant engineering degree, and a