Computer Systems Validation Analyst II

Complete the execution and documentation required per the CSV Program, including all CSV activities, documentation requirements and reports including plans, risk assessments, functional requirements, specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews. Scope includes direct impact laboratory, manufacturing and enterprise (multi-site) applications. Ensure project deadlines and performance standards are met while responding to inquiries from management, end users and clients and providing status updates on a frequent basis. Work collaboratively to ensure and support the timely delivery of validated computer systems for internal clients. Implement action items as assigned for change controls. Manage periodic reviews of computerized systems and data integrity/data quality assessments. Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. Perform miscellaneous duties as assigned. Required Education, Skills, and Knowledge: Degree in Information Technology, Life Science or Technical discipline and/or 2-5+ years of relevant industry experience. Demonstrated project management ability with good written and oral communication skills is required. Knowledge of the computerized system lifecycle activities, CSV, and IT controls in a regulated environment. Experience successfully coordinating and navigating complex issues with internal and external stakeholders. Excellent organizational skills and attention to detail and accuracy.