Systems Test Engineer

United States

Job Description:

Conduct day-to-day software quality assignments of internal and out-sourced software development activities for all clinical trial operations within the company.  Identifies and resolves problems as they arise.  This role is characterized by the responsibilities of an individual who may interact with Project Managers, operations staff, Business Analysts, Systems Developers, and management.  The individual requires minimum supervision and ongoing training to assure consistent performance. The Systems Test Engineer shall be very detail-oriented, possess good documentation skills, and be a self-starter.  The candidate will be capable of collaborating with stakeholders to identify, isolate, and resolve defects found during all phases of the systems product’s test cycle.  Shall demonstrate consistent and cooperative service in support of staff, co-workers, and sponsor personnel.  Must exhibit and maintain a team approach and a positive attitude.  The Engineer shall maintain a current working knowledge of industry regulations supporting e-clinical trials.

Responsibilities & Accountabilities:

  • Support the development of detailed User Requirement Specifications or Project Specifications, and Functional and Design Specifications as applicable.
  • Responsible for developing detailed validation plans to cover the testing strategy, intended use of application, validation and functional risks, and the planned validation activities.
  • Responsible for creating test cases and scripts to adequately verify that the software is performing as intended.
  • Responsible for creating Requirements Traceability Matrixes to ensure that all requirements have been adequately tested.
  • Responsible for developing detailed validation reports covering the results of the validation activities and any issues identified.
  • Effectively manage the issue tracking system.
  • Ensure that issues are documented and resolved in the issue tracking system in a timely manner.
  • Responsible for ensuring that software applications are developed and deployed with the ability to comply with 21 CFR Part 11, Electronic Records; Electronic Signature and Annex 11: Computerized Systems, EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4, GMP Medicinal Products for Human and Veterinary Use.
  • Coordinates procedural or system changes with the Head of Q/RA, who has oversight of this function for Regulatory compliance, to improve the effectiveness of the quality assurance system.

Education & Experience:

  • Bachelor’s degree in computer science or equivalent
  • 1-2 years related experience recommended
  • Experience with Windows operating systems and networks
  • Experience with Java, JavaScript, and SQL is a plus
  • Experience with QA procedures and techniques in a Client/Server and web-based environment
  • Experience in the creation of validation plans, test cases and test plans
  • Experience writing Requirement Specifications is a plus
  • Excellent organization skills
  • Excellent communication skills

Benefits:

  • Competitive Salaries
  • 401(k) matching
  • Generous paid time off and holiday
  • Internet allowance for remote workers
  • Employee assistance program
  • Employee discount
  • Flexible spending account
  • Health savings account
  • Life insurance
  • Professional development assistance
  • Tuition reimbursement

Schedule:

  • 8-hour shift
  • Monday to Friday
  • No weekends

Work Location: Remote

Candidates can send their CV to hr@voiantclinical.com. Please feel free to reach out to HR Talent & Culture with any questions.