Sr. Validation Engineer jobs in United States
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Herbalife · 15 hours ago

Sr. Validation Engineer

Herbalife is seeking a Sr. Validation Engineer to support equipment and process validation activities at their Innovation and Manufacturing facility in Winston-Salem, NC. The role involves leading validation projects, maintaining compliance with regulatory standards, and providing consultation across departments.

Dietary SupplementsFitnessHealth CareNutrition
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H1B Sponsor Likelynote

Responsibilities

Lead Validation/Qualification projects, including:Validation Planning, Validation Schedulingm 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 ValGenesis. Develop and support Validation program to ensure compliance and harmonization across manufacturing facilities
Maintain Standard Operating Procedures (SOPs) related to validation and updates as required to meet current standards
Support development of overall validation strategy, programs and policies, master plans and SOPs pertaining to governance of 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
Create and 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
Other duties as assigned

Qualification

Validation Master PlanGMP experienceTechnical writingStatistical analysisMicrosoft Office SuiteLean ManufacturingValGenesisMechanical systems knowledgeElectronic systems knowledgeAttention to detailTeam collaborationMentorship

Required

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
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
Bachelor's Degree in Chemistry, Engineering or scientific related field

Preferred

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

Benefits

Group Health Programs
Other Voluntary Benefit Programs
Paid Time Off
Medical
Dental
Vision
Health Savings Account (HSA)
Flexible Spending Accounts (FSA)
Basic Life/AD&D
Short-Term and Long-Term Disability
Employee Assistance Program (EAP)
401(k) plan
Wellness Incentive Program
Employee Stock Purchase Plan (ESPP)
Supplemental Life/Critical Illness/Hospitalization/Accident Insurance
Pet Insurance
Company-observed U.S. Holidays
Floating Holidays
Vacation
Sick Time
Volunteer Program
Paid Maternity and Paternity Leave
Bereavement Leave
Personal Leave
Time off for voting

Company

Herbalife

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Herbalife is a nutrition company that offers dietary supplements and products for individuals and distributors.

H1B Sponsorship

Herbalife has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (12)
2023 (28)
2022 (27)
2021 (7)
2020 (96)

Funding

Current Stage
Public Company
Total Funding
$3.1B
2024-04-05Post Ipo Debt· $800M
2022-12-05Post Ipo Debt· $250M
2020-05-29Post Ipo Debt· $600M

Leadership Team

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John DeSimone
Chief Financial Officer
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Phil Carlson
Director of Global Corporate Security
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Company data provided by crunchbase