Systems Test Engineer

Voiantclinical; United States; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading company is hiring a Systems Test Engineer to support software quality assignments for clinical trial operations. The role involves collaborating with multiple stakeholders to identify and resolve issues throughout the software's testing cycle. Ideal candidates will possess strong documentation skills and a team-oriented approach, with responsibilities including developing testing strategies, validation plans, and managing issue resolution.

Benefits

401(k) matching

Generous paid time off and holiday

Internet allowance for remote workers

Employee assistance program

Flexible spending account

Health savings account

Life insurance

Qualifications

• Minimum 1-2 years related experience in software QA.
• Experience with QA procedures in Client/Server and web-based environments.
• Creating validation plans and test cases.

Responsibilities

• Support the development of User Requirement Specifications.
• Develop validation plans and create test cases/scripts.
• Manage the issue tracking system for timely documentation.

Skills

Attention to detail

Documentation skills

Collaboration

Education

Bachelor’s degree in computer science or equivalent

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 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
• 401(k) matching
• Generous paid time off and holiday
• Internet allowance for remote workers
• Employee assistance program
• Flexible spending account
• Health savings account
• Life insurance

Schedule:

• 8-hour shift
• Monday to Friday

Work Location: Remote

Candidates can send their CV [e-mail] . Please feel free to reach out to HR Talent & Culture with any questions.