Validation/Quality Assurance Engineer( EDC)

Our Company

 

At 2,000 employees and growing, and consistently strong financials (NYSE:VEEV), Veeva was named among the top fastest growing public technology companies on Forbesannual Fast Tech 25 list. We build innovative cloud solutions for some of the worlds largest pharmas and biotechs, and we need great people like you to make it happen.

 

Our Culture & People

 

Our core values are Employee Success, Customer Success, and Speed. We are innovators, collaborators, and thought leaders out to create best-in-class solutions that help our customers improve and extend human life. Its genuine, straight-forward, and no fuss.

 

Job Summary

Are you looking to combine your pharmaceutical industry knowledge and regulated systems expertise with world class technology sales and marketing software solutions? Veeva Systems is looking for a self-motivated Validation/Quality Assurance Engineer who will be responsible for supporting the quality and compliance of our EDC application. In this role, you will assess and learn product functionality to determine GxP relevancy and work closely with the product management, engineering, quality, and validation teams  to develop and deliver related Computer Systems Validation documentation including Risk Assessments, Requirement Specifications, and Qualification Test Protocols. You will become an integral part of our development team, who ensures Veeva products are quality SaaS products. To be a part of the Veeva team, you should want to be part of a fast-paced environment who takes pride in building great software and making customers happy.

 

Responsibilities

  • Ensure system compliance with applicable regulations and that all testing is executed and documented according to Standard Operating Procedures and associated processes
  • Perform risk assessment for new and modified functionality to determine GxP impact and appropriate validation approach
  • Work with product managers and developers using Agile methods to identify/refine test cases from requirements and design
  • Work with QA engineers in a team environment to ensure product quality
  • Maintain and configure test environment for the purposes of test review and execution
  • Work closely with Validation team and contribute to and support the development of key computer system validation deliverables
  • Document test cases and outcomes within a test case management application
  • Conduct QA tests and verify outcomes within schedules/timelines
  • Clearly document and explain defects found in defect tracking system

Requirements

  • 4+ years of direct experience with quality assurance and computer system validation within the life sciences industry
  • Proven track record of testing and validating computer systems validation projects
  • Understanding of Software QA methodologies, tools and approaches (black box and/or automated testing) in a software company with short release cycles
  • Advanced knowledge of requirements engineering, test environments, protocol development, and functional risk assessment
  • Bachelors Degree from a 4 year accredited institution 

Nice to Have

  • Experience with EDC and clinical applications
  • Experience with 21 CFR Parts 11 and 203

 

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.

 


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