Sr. Validation Engineer

Overview

The Sr. Validation Engineer will work onsite at our state‑of‑the‑art Innovation and Manufacturing facility in Winston‑Salem, NC and will be responsible for supporting all equipment and process validation activities at Herbalife Innovation and Manufacturing sites. Execution of validation activities is performed to state and regulatory requirements and/or other laws and standards that apply. The role will support all projects required for the expansion and improvement of operations at the production facilities and coordinate all validation activities and projects with departmental managers.

• Lead Validation/Qualification projects, including Validation Planning, Validation Scheduling, Validation Execution, Validation Project Reports, and SOP Preparation and Training
• Develop and maintain Validation Master Plan in support of cGMP requirements and company objectives; develop and optimize master templates for validation protocols in Val Genesis
• Maintain Standard Operating Procedures (SOPs) related to validation and update them as required to meet current standards
• Support development of overall validation strategy, programs, policies, master plans and SOPs pertaining to governance of the validation life cycle
• Act as an authority for validation and provide consultation for other departments such as Engineering, Operations, and QA
• Work with Engineering team to create user requirements specifications (URS) and SAT (Site Acceptance Testing) documents for equipment purchase/installation at HIM facilities
• Create validation protocols and summary reports in compliance with Herbalife standards and/or government regulations
• Coordinate change control and equipment‑related changes, submit change requests for facilities modification and document approvals
• Investigate, document, and resolve protocol deviations in a timely manner; ensure documentation is accurate and deviations are properly addressed
• Participate in audits and inspections as needed
• Provide training and mentorship to junior level staff

• Strong technical writing skills; detailed knowledge of grammar, spelling, punctuation and fundamentals of technical documentation
• High degree of attention to detail
• Proficient with Microsoft Office Suite (including MS Project and Visio)
• Understanding of mechanical systems as they relate to manufacturing equipment, facilities equipment and cleaning systems
• Understanding of electronic systems as they relate to process controls and equipment controls
• Familiarity with materials in relation to manufacturing equipment and their suitability for processing compliance

• 5+ years of validation/qualification and process engineering experience in a GMP environment
• 5+ years of experience with Good Manufacturing Practices and Good Documentation Practices
• Experience in food, nutraceutical, pharmaceutical and/or medical device process development

• Bachelor’s Degree in Chemistry, Engineering or a related scientific field

• Strong statistical analysis background
• Knowledge of PLC and automated controls qualification
• Knowledge of qualification requirements for powder and liquid handling, processing, and packaging
• Basic knowledge of cleaning validation and computer system validation
• Experience with Lean Manufacturing and Continuous Improvement concepts
• Knowledge of ISO
  17025 Standards
• Proficient in VLMS Software such as Val Genesis

• Must be able to see, hear, speak and write clearly to communicate with employees and/or other customers
• Light office work, some light lifting, and walking may be required

• The office is clean, orderly, properly lighted and ventilated
• Noise levels are low to moderate

At Herbalife, we value doing what’s right. We are proud to be an equal‑opportunity employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected characteristic. We value diversity, strive for inclusivity, and believe the differences among our teammates is a key contributor to Herbalife’s ongoing success.

Herbalife offers a…