Engineer, Validation

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:

 

•    Responsible for supporting the Validation/Qualification program by: 
       - 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, 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 (SOP's, 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.
•    Applies 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

SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:

 

Skills:

 

•    Strong technical writing skills with a thorough understanding of good documentation practices, experienced in writing and executing IQ, OQ and PQs, Process Verifications (PVs), and Continuous Verification programs.
•    Well-organized and technically sound in understanding validation principles.
•    Ability to provide consultation and input to support the manufacturing facility as it relates to the qualification or validation process.
•    Ability to prioritize projects and manage assigned resources to meet organizational goals and objectives.
•    Ability to track and update schedules to provide leadership with the  visibility of breakthroughs and achievements
•    Ability to investigate and resolve OOS results, deviations or non-conformances.
•    Technical capability and ability to work in fast paced environment with competing priorities.
•    Ability to operate with minimal direction and supervision and be able to manage and track status of activities.
•    Proficient with Microsoft Office Suite including MS Project and Visio.
•    Excellent teamwork, interpersonal, communication and problem-solving skills.

 

Experience:

 

•    3–5 years of related validation experience in a cGMP environment preferably in food/pharmaceutical based GMP manufacturing facility.
•    Experience with equipment qualification methodologies
•    Experience in cGMP CA/PA, root cause analysis, risk assessment and investigation tools and techniques.

 

 

Education:

 

•    Bachelor’s degree in science/engineering or equivalent technical degree.

 

 

 

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.