Engineer, Validation

Overview

THE ROLE : The Validation Engineer will work onsite at our state of art Innovation and Manufacturing facility in Winston-Salem, NC and will be responsible for planning, executing, and documenting validation activities to ensure that equipment, systems, and processes meet regulatory and quality standards. This role supports the development and implementation of validation protocols (IQ / OQ / PQ), collaborates with multi-functional teams, and ensures compliance with internal procedures and external regulations. The ideal candidate is meticulous, technically proficient, and committed to maintaining a high standard of quality and compliance in a regulated environment.

HOW YOU WOULD CONTRIBUTE :

Responsibilities

• Develop and author validation / qualification protocols at the Herbalife Manufacturing facility for processes, equipment, facilities, and utility systems.
• Implement validation / qualification protocols for processes, equipment, facilities, and utility systems at the Herbalife Manufacturing facility.
• Prepare validation / qualification summary reports for the accomplished protocols.
• Support change control activities and assess validation impact.
• Identify and resolve deviations and non-conformities, ensuring timely CAPA (corrective action / preventive action) activities, and implement continuous improvement opportunities related to validation.
• Evaluate the impact of changes, deviations, and CAPAs.
• Participate in Design Qualification (DQ) reviews to ensure user and functional requirements are met.
• Support periodic requalification / revalidation based on lifecycle approach.
• Maintain validation lifecycle documentation and ensure timely revalidation as needed.
• Participate in audits and inspections, providing validation-related documentation and support.
• Ensure compliance with regulatory guidelines and industry standards.
• Contribute to the development and review of required documentation (SOPs, Protocols, Change Requests / Change Controls) to support validation activities.
• Identify gaps in validation processes and implement efficiency improvements.
• Apply Quality by Design (QbD) principles to enhance product and process robustness.
• Apply standard techniques and procedures to carry out a series of scientific and / or engineering tasks.
• Provide adequate reporting and communication of projects to project manager, collaborators and / or department manager.
• Other duties as assigned.

Supervisory Responsibilities

None

Qualifications

Skills and Background Required

Skills :

Experience :

Education :

Physical Demands

In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be considered to perform the essential functions of the job.

Work Environment

In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be considered to perform the essential functions of the job within the environment.

Benefits and additional information are provided to eligible employees in the U.S. as part of Herbalife's compensation and benefits program.

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