Senior Computer System Validation Engineer

Coalesce Management Consulting; Singapore; On-site; SGD 120,000 - 190,000; Full time

Job summary

Coalesce Management Consulting in Singapore seeks an experienced Senior CSV Engineer to support Emerson DeltaV validation and qualification in regulated pharma/biotech environments. You will plan, execute, and document CSV lifecycle activities across hardware and software, ensuring robust data integrity and compliance with state and global standards.

Ideal candidates bring 5+ years DeltaV CSV experience, strong GMP data integrity knowledge, and hands-on IQ/OQ/PQ, FAT/SAT experience.

Qualifications

• Minimum 5 years of DeltaV CSV experience in regulated life sciences environments.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and GMP Data Integrity.
• Experience with IQ/OQ/PQ, FAT/SAT and validation documentation.

Responsibilities

• Plan, execute and document DeltaV CSV lifecycle activities.
• Prepare and review validation documentation including URS, FS, DS, IQ/OQ/PQ and Traceability Matrices.
• Qualify DeltaV hardware, 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.

Skills

DeltaV CSV experience

Regulatory compliance

Validation documentation

Data integrity

Tools

DeltaV hardware

DeltaV software qualification

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.