DeltaV CSV Engineer – Senior Validation for Pharma

Coalesce Management Consulting

Singapore

On-site

SGD 120,000 - 190,000

Full time

14 days+

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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.