- Senior
- Escritório em Winston-Salem
POSITION SUMMARY STATEMENT:
The Sr. Validation Engineer is responsible for supporting all equipment and process validation activities at
the Herbalife Innovation and Manufacturing sites. Execution of validation activities are done to state and
regulatory requirements, Herbalife and/or other applicable regulations and standards. This role supports all
projects required for the expansion and improvement of operations at the production facilities. This role
coordinates all validation activities and projects with departmental managers.
DETAILED RESPONSIBILITIES/DUTIES:
• Lead Validation/Qualification projects, including:
• Validation Planning
• Validation Scheduling
• Validation Execution
• Validation Project Reports.
• 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 a subject matter expert 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
SUPERVISORY RESPONSIBILITIES:
None
REQUIRED QUALIFICATIONS:
Skills:
• Thorough 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)
• Strong technical writing skills
• 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
• Understanding of materials as they relate to manufacturing equipment and 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
• 5+ years of experience on 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:
• 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
