Validation Engineer

Job Description for Validation Engineer

Role Summary

The purpose of the Validation Engineer is to ensure that products, equipment, and systems meet all applicable safety, quality, and regulatory requirements. They do this by developing and implementing validation plans, conducting tests, analyzing data, and documenting results.

Essential Duties & Responsibilities :

• Assists with developing qualification protocols, and associated reports while adhering to a change management process.
• Supports the execution of equipment / systems qualifications and validation protocols.
• Supports vendor's qualification functions.
• Assists with developing written procedures for operation and preventive maintenance of equipment and systems.
• Assists with developing validation / qualification deliverables such as Requirements Specifications, Risk Assessments, Traceability Matrices, and validation Summary Reports.
• Supports internal groups in the procurement, operation, calibration, and preventive maintenance of equipment / systems to meet business needs in accordance with required schedules or dates.
• Completes all calibration, qualification, and validation documentation with accuracy, completeness, and compliance.
• Regularly reviews, prioritizes, and promptly responds to MFG and QA equipment qualification / system validation and support requests.
• Maintains a positive relationship with all team members while promoting a positive team environment.

Position Requirements :

Employment Classification

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Physical Requirements

Company

EEO Statement