IT Software Validation Specialist

Sotera Health Company

. Develop, review, and execute validation documentation, including Validation Plans/Reports, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and test results .

Posted 10/23/2026full-timeSalt Lake City • Utah • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in validation documentation and software lifecycle processes, with a strong emphasis on quality assurance and compliance with pharmaceutical and medical device regulations. Proficient in technical writing and capable of analyzing test results to ensure adherence to acceptance criteria.

Highest-signal resume keywords

Validation Documentation DevelopmentPharmaceutical Regulations ComplianceSoftware Quality AssuranceTechnical Writing SkillsProblem-Solving Abilities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation PlansInstallation Qualifications (IQ)Operational Qualifications (OQ)Performance Qualifications (PQ)Software Development LifecycleTest PlansTest CasesTroubleshootingQuality AssuranceRegulatory Requirements

Soft Skills

MultitaskingTime ManagementLogicDecision-MakingCollaboration

Tools & Technologies

MS Office Applications

Industry Keywords

21 CFR Part 1121 CFR Part 210/21121 CFR Part 82021 CFR Part 1271ISO 13485GxPQuality Assurance Best Practices

About the role

Key responsibilities & impact

Develop, review, and execute validation documentation, including Validation Plans/Reports, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and test results
Design and implement validation deliverables, test plans, and test cases based on system understanding and analysis of user, functional, and system specifications
Maintain new GxP software/computer systems and changes to existing systems in a state of control
Ensure accuracy and completeness of Software Development Lifecycle and/or IT Validation records
Collaborate with business users and Business Analysts to understand user requirements and functional design specifications
Analyze test results and attach evidence to verify acceptance criteria; provide software QA approval for subsequent activities
Investigate and resolve test case failures and bugs
Participate in release planning sessions
Complete protocol, minor change, and lifecycle documentation on time
Participate in process improvement efforts
Follow applicable regulatory requirements and company policies and procedures
Perform other duties as assigned

Requirements

What you’ll need

Well versed with software lifecycle processes and methodologies, emphasizing quality assurance and testing best practices
Proficient understanding of pharmaceutical and medical device regulations, including 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR Part 820, 21 CFR Part 1271, and ISO 13485
Demonstrated technical writing skills
Working knowledge of MS Office applications
Ability to multitask and manage changing deadlines
Ability to troubleshoot complicated issues across multiple systems and drive resolution
Ability to work with minimal supervision and manage time effectively
Demonstrated logic, problem-solving, and decision-making skills
Regular and reliable attendance
Must be able to stand/walk 10% of the day and spend 90% sitting at a desk or computer
Must be able to occasionally lift a minimum of 10 lbs
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

Benefits

Comp & perks

Required training completed on time
Hybrid work arrangement