Duties of Equipment Validation Engineer

• Validation Engineer will help in qualification of equipment in pharmaceutical, biotech, medical devices, diagnostics, consumer products, cosmetics and veterinary industries.
• Validation Engineer provides his services in Temperature Mapping of extreme temperature environments such as cryogenic environments and tunnels as well as the more usual equipment such as autoclaves, warehouses and stability cabinets using Kaye Instruments and Data loggers. The Kaye application software can be configured to perform data calculations such as minimum, maximum, average, lethality, etc.
• Developing and executing commissioning plans that support the overall project schedule.
• Developing commissioning documents (e.g., User Requirement Specification, inspection forms, Factory Acceptance Tests and Site Acceptance Tests).
• Performing GxP, Calibration and System impact assessments.
• Executing commissioning activities for utility and process equipment systems in a manner that maximizes opportunities for leveraging with qualification activities.
• Validation Engineer also helps in qualification of classified environments, containment solutions, clean systems and highly complex process equipment.
• Risk Assessments, Vendor audits and Validation Master Plan (VMP).
• Qualification Protocol (IQ, OQ, PQ) Development and Qualification Protocol Execution.
• Validation Reporting.
• Traceability Matrices.
• SOP Development and Review.
• Validation Project Management.
• Validation Gap Analysis and Remediation.