Sr. Engineer, Validation
Job
Herbalife
Winston-Salem, NC (In Person)
Full-Time
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Job Description
Sr.
Engineer, Validation Category:
Quality Position Type:
Regular Full-Time External ID:
18580Location:
Winston-Salem, NC, United States Date Posted:
Mar 24, 2026Share:
share to e-mail Tweet share to twitter Share on Facebook share to facebook Share on LinkedIn share to linkedin- Overview
THE ROLE
- The Sr.
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
- Qualifications
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.
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.
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