Job Description
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).
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