Sr. Engineer, Validation

THE ROLE:

 

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

 

HOW YOU WOULD CONTRIBUTE:

 

 Will lead and manage  validation and qualification activities to ensure compliance with cGMP requirements, company standards, and regulatory expectations across manufacturing facilities.

 

• Project Leadership: Lead validation and qualification projects from planning and scheduling through execution, reporting, and SOP development/training.
• Validation Governance: Develop and maintain the Validation Master Plan, validation templates in ValGenesis, and a harmonized validation program across sites.
• SOP Management: Create, update, and maintain validation-related SOPs to align with current standards and regulatory requirements.
• Strategy & Compliance: Support development of validation strategy, policies, life-cycle governance, and overall compliance frameworks.
• Technical Expertise: Serve as a validation authority, consulting with Engineering, Operations, and QA.
• Documentation Support: Work with Engineering to create URS and SAT documents for new equipment; prepare validation protocols and summary reports.
• Change Control: Coordinate equipment changes, submit facility modification change requests, and ensure proper documentation and approval.
• Deviation Management: Investigate and resolve protocol deviations, ensuring accurate documentation and timely closure.
• Audit Support: Participate in internal and external audits and inspections.
• Training & Mentorship: Train and mentor junior staff.
• Additional Duties: Perform other assigned tasks supporting validation and compliance activities.

SUPERVISORY RESPONSIBILITIES:

 

 

None

SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:

 

Skills:

• Strong technical writing skills. Detailed knowledge of grammar, spelling, punctuation and the fundamentals of technical
documentation
• Demonstrates a high degree of attention to details
• 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

 

Experience:

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

 

Education:

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

 

 

PREFERRED QUALIFICATIONS: 

 

Skills:

• 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 ISO17025 Standards
• Proficient in VLMS Software such as ValGenesis

 

 

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.

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

 

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.

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

   

 

 

 

 

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Herbalife offers a variety of benefits to eligible employees in the U.S. (limited to the 50 States and the District of Columbia), which includes Group Health Programs, other Voluntary Benefit Programs, and Paid Time Off. Group Health Programs include Medical, Dental, Vision, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Basic Life/AD&D; Short-Term and Long-Term Disability, and an Employee Assistance Program (EAP). Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance. Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.