Validation Engineer

Position Overview

The Validation Engineer plays a key role in ensuring systems, equipment, and processes operate in a compliant and controlled state. This role is responsible for planning, coordinating, and executing validation and qualification activities across manufacturing processes, cleaning systems, equipment, computerized systems, and facilities. The position supports both routine validation needs and larger project-based initiatives, including collaboration with external partners when required.

Key Responsibilities

• Execute and manage validation and qualification activities to support new, modified, and existing systems across the site.
• Ensure validation work aligns with internal procedures, regulatory expectations, and applicable industry standards.
• Develop, review, and execute validation and qualification protocols, including initial qualification and requalification activities.
• Maintain accurate, complete, and current validation documentation and records.
• Partner with cross-functional teams, equipment vendors, and external resources to support successful project execution.
• Coordinate document reviews and approvals with operations, quality, and other stakeholder groups.
• Lead hands-on execution of validation activities for processes, cleaning systems, equipment, computerized systems, and facilities.
• Track and maintain qualification status and documentation for validated assets across the site.
• Provide technical expertise and troubleshooting support during validation execution and issue resolution.
• Ensure validation activities are performed safely, efficiently, and in compliance with established standards.
• Support additional validation initiatives and projects as assigned by leadership.