Sr. Validation Engineer

Herbalife • Winston-Salem, NC

2d • Onsite

About The Position

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 : 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

Requirements

• 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

Nice To Haves

• 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

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees