Computer System Validation (DeltaV)

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

We are seeking aComputer System Validation (CSV) Engineer with experience in Emerson DeltaV systemsto 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