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Engineer, Computer Validation

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Quality
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180603 Requisition #

 

 

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:

 

This position is responsible to develop, execute and review of Computer System Validation/Qualification (including change control management) for our GMP-related computer systems following 21 CFR Part 11, GAMP 5 and Herbalife Nutrition standards.


 

DETAILED RESPONSIBILITIES/DUTIES: 

  • Responsible for developing, authoring and reviewing User Requirement Specifications (URS), Functional Requirements (FR) and Design Specifications (DS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Trace Matrices (TM), Risk Assessments (RA) and Impact Assessment (IA)/Change Control documents.
  • Author, review and execute test scripts to be used for conference room pilot activities and for software development testing.
  • Execute validation/qualification protocols for computerized systems utilized at Herbalife Nutrition.
  • Prepare and/or review validation/qualification summary reports for the executed protocols
  • Ensures that the system’s validation state is maintained through proper testing as part of the change control program and re-validation as necessary.
  • Manages and administer new user requests for EBR and Agile.
  • Serves as one of the Agile Change Request (ACR) approver for QA.
  • Responsible to gather user requirements for developing data trending and analytics charts/dashboards (i.e. in the Oracle Business Intelligence platform).
  • Support QMS team in developing dashboards/charts and performing testing and validation of data trending and analytics charts/dashboards.
  • Develop and revise Standard Operating Procedures (SOPs), Job Aids and guidelines for Quality systems and applications.
  • Collaborate with business partners and end users to meet project goals, system validation and change control requirements.
  • Interacting with QMS or IS (for in-house applications) and vendors (for third party applications) to obtain the necessary documents to complete validation activities.
  • Responsible to produce high quality data, and empowered to stop an analysis that may produce poor quality results as required by 21 CFR part 11 and cGMP.
  • Periodically audit the system to ensure compliance.
  • Provide validation status and validation project updates to project manager/lead.
  • Other Duties as assigned

REQUIRED QUALIFICATIONS:


Skills:

  • Detail oriented and ability to work in a fast paced environment with the ability to handle a multitude of projects with overlapping deadlines.
  • Strong verbal and written communication skills.
  • Strong technical writing skills.
  • Ability to function as an effective team player.
  • Experience with Agile framework and scrum methodology.
  •  Experience with Oracle PL/SQL, SQL or MySQL.

Experience:

  • Minimum of 3 years of related experience in a quality, regulatory, manufacturing or IT/IS function.
  • Training and knowledge of validation methodologies and principles and knowledge of 21 CFR part 11 or equivalent.
  • Experience in writing and/or reviewing technical documents, especially test scripts or computer systems validation documents.

Education:

  • Bachelor’s Degree in Informational Technology, Science, or Engineering.

PREFERRED QUALIFICATIONS:

  • Experience with project management tools.
  • Knowledge using Power Query, Python or R for data analysis.
  • Experience in GAMP 5 and general principles of software validation a plus.
  • Computer System validation experience in a food, nutraceutical or pharmaceutical based GMP manufacturing facility.

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