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Senior Validation Engineer

The Senior Validation Engineer is responsible for working with the client implementation team to manage the validation effort of enterprise level software implementations.  The Senior 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.

  • Coordinating all validation activities (IQ/OQ/PQ or UAT) across client engagements via constant communication with affected departments and personnel
  • Responsible for assisting with the development of procedures, specifications, validation master plans and risk assessments (e.g., FMEA)
  • 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
  • 3+ 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
  • Excels in high-growth environment enabling product, team, and overall organizational growth via long-term perspective, team and customer relationship building, and development of operational infrastructure, e.g. processes, policies, and procedures
  • Takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed
  • Demonstrated ability to meet deadlines and multi-task in a fast-paced work environment

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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