Sr. Engineer, Validation

3 weeks ago

WinstonSalem, United States Herbalife Full time

Overview:

THE ROLE:

The Senior Validation Engineer is responsible for all equipment and process validation activities working onsite at the Herbalife Innovation and Manufacturing site in Winston Salem, North Carolina. Execution of validation activities are done to state and federal regulatory requirements, Herbalife and/or other regulations and standards. The validation engineer develops authors and executes all validation protocols. The Sr. Validation Engineer assigns validation activities to Validation Technician and Validation Engineer as needed. The Sr. Validation Engineer summarizes results in final validation reports. The Sr. Validation Engineer supports all projects required for the expansion and improvement of operations at the production facility. The validation engineer coordinates all validation activities and projects with departmental managers.

HOW YOU WOULD CONTRIBUTE:

  • Leads Validation/Qualification projects including
  • Validation Planning
  • Validation Scheduling
  • Validation Execution
  • Validation Project Reports.
  • SOP Preparation and Training
  • Maintains the Master Validation/Qualification Plan
  • Maintains SOP's (Standard Operating Procedures) related to validation and updates as required to meet current standards.
  • Creates validation protocols and summary reports in compliance with Herbalife standards and/or government regulations.
  • Co-ordinates change control and equipment related changes
  • Creates and submits change requests for facilities modification and document approvals.
  • Investigates, documents, and resolves protocol deviations in a timely manner.
  • Ensures that documentation is accurate, and deviations are properly addressed.
  • Create and submit change requests for new equipment.
  • Assign work to Validation Technician and Validation Engineer
  • Work in team environment to meet qualification standards and timelines.
  • Other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

None

Job Qualifications:

SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:

Skills:

  • Thorough knowledge of grammar, spelling, punctuation, and the fundamentals of technical documentation
  • Demonstrates a high degree of attention to details
  • Proficient with Microsoft Word and Microsoft Excel
  • 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:

  • Minimum 4 years of validation/qualification and process engineering experience in a GMP environment
  • Minimum 3 years of experience on Good Manufacturing Practices
  • Minimum 3 years of experience on Good Documentation Practices
  • Experience in food, pharmaceutical and/or medical device process development

Education:

  • Bachelor's Degree in scientific or related field

PREFERRED QUALIFICATIONS:

  • Proficient with Microsoft Office Suite, Adobe, Project and Visio
  • Strong statistical analysis background
  • Strong mechanical aptitude
  • Knowledge of PLC and automated controls qualification
  • Knowledge of qualification requirements for powder and liquid handling, processing, and packaging
  • Validation experience of equipment cleaning methodologies
  • Bachelor of Science Degree in chemistry or engineering field

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

#LI-JH1

US Benefits Statement:
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.

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