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Validation Engineer

The Validation Engineer is responsible for working with the client implementation team to support the validation effort of enterprise level software implementations.  The Validation Engineer will be responsible for coordinating and managing the testing process including the creation of test scripts, supporting user acceptance testing and executing IQ/OQ/PQ/UAT test scripts.  The Validation Engineer will also assist with the development and documentation of testing processes and procedures. 

Essential Duties and Responsibilities:

Note:  Other duties may be assigned.

  • Reviewing functional and technical specifications to develop test plans
  • Developing test scripts to do functional testing, regression testing, and load testing
  • Performing manual testing focusing on functional and end-to-end testing, validating that system response and output accurately reflect business requirements as outlined in requirements document
  • Validating that data loading and storage structures operate according to technical specifications and well accepted standards
  • Executing testing plans and the creation/management of issues
  • Participating in reviews at all phases of the software development cycle
  • Contributing to overall Quality Assurance best practices, strategy and methodology

Education and Experience

  • Bachelor's degree (preferably in Computer Science or a related field) or 4 or more years of directly related experience
  • 1+ years' experience in validation of software or in IQ/OQ/PQ phases of a validation effort
  • Experience in GxP (GCP, GLP, GMP) or regulated environment
  • Experience in 21 CFR Part 11 and Annex 11, Computer Software Validation
  • Hands-on experience in testing complex business applications and understanding large complex environments and knowledge of requirements based testing
  • Experience, AGILE, SCRUM, or Waterfall environment experience is also a plus
  • Strong interpersonal, verbal and written communication skills mandatory
  • Keen attention to detail, well organized, good decision-making skill, self-management skills
  • Demonstrated ability to meet deadlines and multi-task in a fast-paced work environment
  • Must have very strong skills with Microsoft Office applications
  • Must be comfortable working with business users and technical teams
  • Familiarity with GxP and 21 CFR Part 11 is a plus
  • Familiarity with defect tracking software is a plus
  • Familiarity with test automation, load/performance testing, and test case management software a plus

We offer a highly competitive base salary and an outstanding benefits program, including medical, prescription drug, dental, vision, 401(k) with Company match, life insurance, and generous paid time off.

We are an Equal Opportunity Employer, M/F/D/V

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