Computer System Validation Engineer (DeltaV)

Coalesce Management Consulting; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

DeltaV systems

Validation principles

Regulatory compliance

Data integrity

Education

Bachelor's degree in engineering or related field

Tools

Emerson DeltaV

Job description

We are seeking a Computer System Validation (CSV) Engineer with experience in Emerson DeltaV systems to support the validation and lifecycle management of automated and computerized systems within a regulated manufacturing environment. The successful candidate will be responsible for ensuring computerized systems are appropriately validated and maintained in compliance with applicable GMP requirements, data integrity principles and internal quality standards.

Key Responsibilities

• Develop, review and execute Computer System Validation documentation for DeltaV and other GMP computerized systems.
• Prepare validation deliverables including User Requirement Specifications (URS), Functional Specifications, Design Specifications, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, traceability matrices and validation reports.
• Perform risk-based validation activities throughout the system lifecycle.
• Support validation of DeltaV Distributed Control Systems (DCS), including system configuration, recipes, control modules, batch processes and associated interfaces.
• Review system configuration and automation documentation to ensure alignment with approved requirements and GMP expectations.
• Execute and document validation test scripts, including functional, security, alarm, audit trail and data integrity testing.
• Investigate and document validation deviations, discrepancies and test failures, and support resolution and CAPA activities.
• Support system changes through change control and assess the validation impact of software, hardware and configuration modifications.
• Support periodic reviews, system retirement and lifecycle documentation activities.
• Work closely with Automation, Engineering, IT, Quality Assurance, Manufacturing and vendors throughout project execution.
• Ensure computerized systems comply with relevant regulatory requirements and industry standards including GAMP 5, 21 CFR Part 11, EU Annex 11 and applicable data integrity requirements.
• Support regulatory inspections and internal or external audits when required.

Requirements

• Bachelor's Degree in Engineering, Computer Science, Information Technology, Pharmaceutical Sciences or a related discipline.
• Experience in Computer System Validation within pharmaceutical, biotechnology, medical device or other regulated manufacturing environments.
• Hands-on experience or strong working knowledge of Emerson DeltaV systems.
• Good understanding of the computerized system lifecycle and risk-based validation principles.
• Minimum 3-4 years of work experience with DeltaV