Senior Computer System Validation Engineer

Coalesce Management Consulting; Singapore; On-site; SGD 150,000 - 210,000; Full time

Job summary

Coalesce Management Consulting is seeking an experienced Senior CSV Engineer to validate DeltaV systems within regulated pharma/biotech environments in Singapore. You will plan, execute and document CSV lifecycle activities and review validation artifacts across URS, FS, DS, IQ/OQ/PQ, and Traceability Matrices.

The role requires ensuring data integrity, electronic signatures, and audit trails. You will qualify DeltaV hardware/software, support FAT/SAT and commissioning, and collaborate with

Qualifications

• Experience with DeltaV CSV in regulated life sciences environments.
• Strong knowledge of CSV lifecycle activities and validation concepts.
• Familiarity with data integrity, electronic signatures and audit trails.

Responsibilities

• Plan, execute and document DeltaV CSV lifecycle activities.
• Prepare and review validation documentation (URS, FS, DS, IQ, OQ, PQ).
• Qualify DeltaV hardware and software configurations, control modules and batch recipes.
• Support FAT, SAT, commissioning, qualification and regression testing.
• Ensure compliance with data integrity, audit trail, electronic signatures and security requirements.
• Support deviations, change controls and discrepancy resolution.
• Collaborate with Automation, CQV, Quality, IT and Manufacturing teams.

Skills

DeltaV CSV experience

GAMP 5 familiarity

FDA 21 CFR Part 11

EU Annex 11

GMP Data Integrity

Job description

We are looking for an experienced Senior CSV Engineer to support the validation and qualification of Emerson DeltaV systems within a regulated pharmaceutical or biotechnology environment.

Key Responsibilities

• Plan, execute and document DeltaV CSV lifecycle activities.
• Prepare and review validation documentation including URS, FS, DS, Risk Assessments, IQ, OQ, PQ, Traceability Matrices and Validation Reports.
• Qualify DeltaV hardware infrastructure, software configurations, control modules, equipment modules and batch recipes.
• Support FAT, SAT, commissioning, qualification and regression testing activities.
• Ensure compliance with data integrity, audit trail, electronic signature, backup/restore and security requirements.
• Support deviations, change controls and discrepancy resolution.
• Collaborate with Automation, CQV, Quality, IT and Manufacturing teams.

Requirements

• Minimum 5 years of DeltaV CSV experience within pharmaceutical, biotechnology or other regulated life sciences environments.
• Strong experience in DeltaV hardware and software qualification.
• Good working knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and GMP Data Integrity requirements.
• Experience with IQ/OQ/PQ, FAT/SAT and validation documentation.