Job Type: Full Time
Description and Requirements
SUMMARY OF POSITION: The Software Test Engineer will handle validation efforts in support of implementation of WCG applications and client initiatives. The Software Test Engineer will also assist in the implementation of critical systems and services in support of WCG applications and client initiatives as required. The activities shall involve but may not be limited to: project management of testing efforts, creating validation test packages, test case creation, test execution, validation remediation, QC of client-specific configurations, and support of client testing efforts. The Software Test Engineer will be responsible for implementing overall testing and validation procedures of WCG computer applications in alignment with applicable guidelines and regulations. EDUCATION REQUIREMENTS: Requires a bachelor’s degree or the equivalent
Bachelor’s degree (or foreign equivalent) in Computer Science, or a related field and
5 years of: software testing and validation experience in an Agile or Waterfall development methodology environment; and experience authoring tests, executing tests, reporting issues and providing evidence and reproducible steps using defect management tools Jira and Helix ALM.
Must have 4 years of experience: testing software in the Life Sciences industry including 21 CFR Part 11 testing; performing SQL queries; and processing documents in the document management application.
At least 5 years of experience in validation testing, preferably in the Pharmaceutical industry. Ability to effectively work with Developers, Business Analysts, and Quality Assurance team members. Close familiarity with most of the field’s concepts, practices, and procedures. Experience validating systems compliant with 21 CFR Part 11 regulations.
Experience with manual and automated testing processes and tools. Ability to communicate effectively in both verbal and written form. Ability to collect, aggregate, organize, and analyze data. Experience in analyzing and documenting customer business processes. Proven leadership skills, with ability to provide cross-functional leadership throughout the organization.
ESSENTIAL DUTIES/RESPONSIBILITIES: · Participate in validation efforts for client initiatives · Manage tasks and timelines · Assign tasks to additional validation team members · Partner with the Test Manager and Validation Compliance to prioritize and provide status for validation projects · Design test scenarios with traceability to system requirements and design specifications · Attendance and punctuality are essential functions of the position
· Perform documentation reviews
· Report and monitor bugs in the official WCG bug tracking system
· Act as primary liaison in support of client specific testing efforts
· Periodically conduct training for other team members
· Provide input to/enforce WCG standard testing methodologies, procedures and practices
· Work extensively on the IRB/Clinical Trial applications & 21 CFR Part 11 regulations
Qualifications and Experience
· Citrix experience
· Working knowledge of Clinical Trial Process & 21 CFR Part 11 regulations is required.
· Agile Scrum experience
WCG is proud to be an equal opportunity employer – Qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law.
Mid-level industry position
Puyallup , United States