Sr. Engineer, Validation

Overview

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

Job Qualifications

Skills and background required to be successful :

Skills :

Experience :

Education :

Preferred qualifications :

Skills :

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.

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.

teamherbalife

HerbalifeManufacturing

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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