QA MES, DeltaV HBV
Posted:
25 June 2026 (30+ days ago)
Application Deadline:
22 September 2026
Vacancies:
1 Vacancy
Job Summary
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.