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QA - MES, DeltaV HBV

Advanced Manufacturing Tech Solutions · Singapore

Singapore · On-siteFull-TimePosted Jun 24, 2026

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QA Engineer – MES, DeltaV, HBV

Key Responsibilities & Requirements:

Ensure quality oversight of MES, DeltaV, and HBV systems in pharma manufacturing.
Develop and execute validation protocols (IQ/OQ/PQ) in compliance with GAMP 5, 21 CFR Part 11, Annex 11.
Perform functional, integration, and regression testing for MES workflows and DeltaV batch configurations.
Review and approve CSV documentation including test scripts, deviations, and change controls.
Support commissioning and qualification of DeltaV hardware/software and HBV systems.
Collaborate with automation, process, and QA teams to resolve system issues.
Ensure audit readiness by maintaining validation records and compliance reports.
Drive paperless validation initiatives and digital transformation (Pharma 4.0).
Provide QA input during system upgrades, patches, and migrations.

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