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Engineer, Computer Validation

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Quality
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180603 Requisition #
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About Herbalife Nutrition

 

Herbalife Nutrition is a global nutrition company whose purpose is to make the world healthier and happier.  We have been on a mission for nutrition - changing people's lives with great nutrition products & programs - since 1980. Together with our Herbalife Nutrition independent distributors, we are committed to providing solutions to the worldwide problems of poor nutrition and obesity, an aging population, skyrocketing public healthcare costs and a rise in entrepreneurs of all ages.  Herbalife Nutrition offers high-quality, science-backed products, most of which are produced in Company-operated facilities, one-on-one coaching with an Herbalife Nutrition independent distributor, and a supportive community approach that inspires customers to embrace a healthier, more active lifestyle.

 

Herbalife Nutrition’s targeted nutrition, weight-management, energy and fitness and personal care products are available exclusively to and through dedicated distributors in more than 90 countries.  

Through our corporate social responsibility efforts, Herbalife Nutrition supports the Herbalife Family Foundation (HFF) and its Casa Herbalife programs to help bring good nutrition to children in need. Herbalife Nutrition is also proud to sponsor more than 190 world-class athletes, teams and events around the globe, including Cristiano Ronaldo, the LA Galaxy, and numerous Olympic teams.

Herbalife has over 8,000 employees worldwide, and our shares are traded on the New York Stock Exchange (NYSE: HLF) with net sales of approximately $4.4 billion in 2017. To learn more, visit Herbalife.com or IAmHerbalife.com.

 
POSITION SUMMARY STATEMENT:

 

The Quality Assurance Computer Validation Engineer is based in Torrance, CA and is responsible for the review and assurance of validation and change control for our GMP-related computer systems following 21 CFR Part 11, GAMP 5, and Herbalife standards. 

 

 

DETAILED RESPONSIBILITIES/DUTIES: 

 

  • Review computer system validation (CSV) documents as needed for GMP systems including risk assessments, IQ, OQ, PQ, User Requirements, Functional Specifications, Traceability Matrix, UATs, Validation Plan and Validation Summary Report.
  • Evaluate changes to validated computer systems to confirm proper testing and documentation.  Includes the Agile system, Electronic Batch Records, Oracle ERP and Novatech LIMS and others.
  • Serve as the Agile Change Request (ACR) approver for QA at the multiple evaluation phases.
  • Review new user requests for EBR and Agile to ensure proper permission levels are granted.
  • Help conduct audits of these validated computer systems for change control, access and validation documentation.
  • Participate as the QA representative for project teams developing new computer systems, resolving issues or developing metrics/reports.
  • Support the organization of QA documentation, assemble documentation for audits, and ensure storage and retention in compliance with federal regulations.
  • Administer the Quality Sharepoint portal, or BOX replacement.
  • Collaborate with Information Systems, Quality Management Systems, Agile Support, Validation, and other groups as necessary for system validation and change control requirements. Other duties as assigned.

REQUIRED QUALIFICATIONS:

 

Skills:

  • Understanding of Good Manufacturing Practices, change control, documentation and validation for FDA regulated industries.
  • Excellent verbal and written communication skills.  Comfortable in small group and large group settings.
  • Strong computer skills, with ability to learn technical software. Proficient in Microsoft Office suite, especially Word and Excel. 
  • Must be detail oriented, self-motivating, and able to work with a sense of urgency in a fast-paced environment.
  • Ability to develop positive relationships and work cross functionally

Experience:

  • Minimum of 3 years related experience in a quality, regulatory or manufacturing function for a regulated industry.
  • Experience managing databases or conducting validation studies.

Education:

  • Bachelor's Degree in Science, Quality, Engineering or Computer Science.

PREFERRED QUALIFICATIONS:

  • Training and knowledge of computer validation methodologies and principles, such as 21 CFR Part 11 and GAMP 5.
  • Experience in writing and/or reviewing technical documents, especially validation reports.
  • Demonstrated knowledge of Quality principles and responsibilities.
  • Certified Software Quality Engineer (CSQE) from ASQ.
  • Specialized knowledge in computer programming, statistical process control, or equipment & process qualification.

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