NMI is hiring a Computer Systems Validation Analyst II

Computer Systems Validation Analyst II Remote Overview The Computer Systems Validation Analyst II supports comprehensive aspects of the Computer Systems Validation (CSV) Lifecycle. This professional will generate documentation, execute implementation tasks, prioritize work, and support escalation management activities while ensuring rigorous compliance with regulatory standards. They must demonstrate the ability to work independently or collaboratively to deliver computer system validation projects efficiently and within budgetary constraints. Essential Functions and Responsibilities - Proficiency with regulatory frameworks including 21 CFR Part 11, Annex 11, GAMP 5, and data integrity ALCOA+ principles - Complete comprehensive execution and documentation for CSV activities, encompassing plans, risk assessments, user requirements, functional specifications, data integrity evaluations, testing, change controls, traceability matrices, qualification protocols, validation and compliance reviews across laboratory, manufacturing, and enterprise applications - Experience with Agile, Waterfall, and hybrid Software Development Life Cycle models for regulated systems - Ensure project deadlines and performance standards are met while providing frequent status updates and responding to management and client inquiries - Collaborate effectively to support timely delivery of validated computer systems - Implement assigned change control action items - Manage periodic reviews of computerized systems and data integrity/quality - Adhere to organizational core values, policies, procedures, and business ethics - Perform additional duties as assigned Required Education, Skills, and Knowledge - Degree in Information Technology, Life Science, or Technical discipline - 5+ years of relevant industry experience - Demonstrated project management capabilities with excellent written and verbal communication skills - Comprehensive knowledge of computerized system lifecycle activities, CSV, and IT controls in regulated environments - Detail-oriented mindset ensuring documentation accuracy and compliance - Ability to coordinate and navigate complex interdepartmental issues - Highly organized with precision-focused approach - Self-motivated professional capable of independent work managing multiple validation activities - Proactive with ability to anticipate validation requirements and drive tasks to completion with minimal supervision Physical Demands and Activities - Ability to remain stationary standing or sitting for extended periods - Capability to move within office environment and exert up to 10 pounds of force - Visual acuity for data analysis, computer screen interaction, and extensive reading - Repetitive motion involving wrist, hands, and fingers - Effective communication skills for information exchange Mental Capabilities Clear conceptual thinking, excellent judgment, troubleshooting, problem-solving, analytical skills, stress management, multi-priority handling, and deadline adherence Work Environment Professional workplace or remote office setting utilizing standard office equipment. Remote employees expected to maintain safe, hazard-free workspaces. The statements describe general work nature and level. Management retains discretion to modify position duties. Equal opportunity employer committed to diverse and inclusive work environment. Applicants considered without discrimination.