DeltaV CSV Engineer - Regulated Systems Validation Expert

Coalesce Management Consulting; Singapore; Presencial; SGD 90 000 - 130 000; Tempo integral

Resumo da oferta

Coalesce Management Consulting is seeking a Computer System Validation (CSV) Engineer with hands-on Emerson DeltaV experience to support validation and lifecycle management of GMP computerized systems. You will ensure systems remain in compliance with GMP, data integrity principles, and internal standards.

The role includes developing and executing validation documents, performing risk-based validation across the lifecycle, and collaborating with QA, IT, Manufacturing and vendors to support

Qualificações

• Bachelor’s degree in a relevant engineering, computer science, or related discipline.
• 3–4 years of experience in computer system validation within regulated environments.
• Hands-on DeltaV experience and understanding of lifecycle validation, data integrity, and GMP.

Responsabilidades

• Develop, review and execute CSV documentation for DeltaV and GMP systems.
• Prepare validation deliverables including URS, FS, DS, IQ/OQ/PQ protocols, traceability matrices and reports.
• Perform risk-based validation across the system lifecycle.
• Support DeltaV DCS validation including configurations, recipes, control modules, and interfaces.
• Review configuration and automation documentation to ensure GMP alignment.
• Execute and document validation tests (functional, security, audit trail, data integrity).
• Investigate deviations and CAPA, support change control and retirement activities.
• Collaborate with Automation, Engineering, IT, QA, Manufacturing and vendors.

Conhecimentos

DeltaV systems

Validation principles

Regulatory compliance

Data integrity

Formação académica

Bachelor's degree in engineering or related field

Ferramentas

Emerson DeltaV

Descrição da oferta de emprego

Coalesce Management Consulting is seeking a Computer System Validation (CSV) Engineer with hands-on Emerson DeltaV experience to support validation and lifecycle management of GMP computerized systems. You will ensure systems remain in compliance with GMP, data integrity principles, and internal standards.

The role includes developing and executing validation documents, performing risk-based validation across the lifecycle, and collaborating with QA, IT, Manufacturing and vendors to support