QA - MES, DeltaV HBV (MES Opscenter)
On-siteSingapore, Singapore
Job Summary
Oversee quality of MES, DeltaV, and HBV systems in pharma manufacturing by developing and executing validation protocols (IQ/OQ/PQ) compliant with GAMP 5, 21 CFR Part 11, and Annex 11. Perform functional, integration, and regression testing for MES workflows and DeltaV batch configurations while reviewing CSV documentation for test scripts, deviations, and change controls. Support commissioning of DeltaV hardware/software and HBV systems, collaborate with automation and process teams to resolve issues, and ensure audit readiness through maintained validation records. Provide QA input during system upgrades, patches, and migrations while driving paperless validation initiatives and digital transformation efforts.
Required Qualifications
- QA oversight of MES, DeltaV, and HBV systems in pharma manufacturing
- Development and execution of validation protocols (IQ/OQ/PQ) in compliance with GAMP 5, 21 CFR Part 11, Annex 11
- Functional, integration, and regression testing for MES workflows and DeltaV batch configurations
- Review and approval of CSV documentation including test scripts, deviations, and change controls
- Support for commissioning and qualification of DeltaV hardware/software and HBV systems
- Collaboration with automation, process, and QA teams to resolve system issues
- Maintenance of validation records and compliance reports to ensure audit readiness
- Experience with paperless validation initiatives and digital transformation (Pharma 4.0)
- Input during system upgrades, patches, and migrations
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