QA - MES, DeltaV HBV (MES Opscenter)

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.