> Markdown version of [/jobs/ext/4199100-it-software-validation-specialist](https://www.wearedevelopers.com/jobs/ext/4199100-it-software-validation-specialist). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # IT Software Validation Specialist - **Company:** Nelson - **Location:** Taylorsville, UT, United States - **Experience:** Experienced - **Contract:** Permanent contract - **Skills:** Testing (Software), Software Engineering, Test Case, Information Technology, GXP - **Published:** October 22, 2026 - **Apply:** https://www.jofdav.com/jobs/60260978-it-software-validation-specialist ## About the Role * Well versed with software lifecycle processes and methodologies, with an emphasis on quality assurance and testing best practices * Proficient understanding of Pharmaceutical and Medical Device regulations including but not limited to 21CFR Part 11, 21 CFR Part 210/211, 21CFR Part 820, 21CFR Part 1271 and ISO 13485 * Demonstrated technical writing skills * Working knowledge of MS Office applications * Ability to multi-task and deal with changing deadlines * Ability to troubleshoot complicated issues across multiple systems, regardless of architecture and driving the effort to a successful conclusion * Ability to work with minimal supervision, managing own time effectively * Demonstrated logic, problem solving, and decision making skills * Regular and reliable attendance Physical requirements: * Must be able to stand/walk 10% of the day and 90% spent sitting at a desk or on the computer. Must be able to occasionally lift a minimum of 10lbs. Education and experience requirements: * BS degree in Engineering, Computer Science or Physical/Life Science; Associate degree or equivalent experience required. * At least 2 years in a BA, QA, Laboratory or IT role ## Description The IT Software Validation Specialist position is responsible for developing, reviewing, and executing validation documentation including Validation Plans/Reports, , Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ) and test results to maintain computerized systems and applications in a validated state. Essential job functions: * Design and implement validation deliverables / test plans and test cases, based on system understanding and analysis of user, functional and system specifications. * Ensure new GxP software / computer systems and changes to existing systems are maintained in a state of control. * Ensure accuracy and completeness of Software Development Lifecycle and/or IT Validation records (e.g., Validation Plan, IQ, OQ, PQ, Minor Change Record) * Collaborate with business users and Business Analysts to understand user requirements and functional design specifications. * Analyze test results and attach evidence to ensure acceptance criteria are adequately met; provide software QA approval to proceed with subsequent activities. * Ensure test case failures or bugs are adequately investigated and resolved. * Participate in release planning sessions to meet release schedule * Ensure timely documentation of Protocol or minor change records and lifecycle documentation. * Participate in process improvement efforts * Perform other duties as assigned. Regulatory & Compliance * Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.). * Know and follow company policies and procedures.