Sr. Engineer, Validation

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 applicable regulations and standards. 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 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 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
 

SUPERVISORY RESPONSIBILITIES:

 

None

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.  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.