Remote CSV Analyst II - Validation & Compliance

IOVANCE BIOTHERAPEUTICS, INC.; United States; À distance; USD 120 000 - 135 000; Plein temps

Résumé du poste

Iovance Biotherapeutics, Inc. is hiring a Computer Systems Validation Analyst II to support CSV lifecycle activities and ensure compliance with 21 CFR Part 11, Annex 11 and data integrity.

The role requires delivering validated computer systems for internal clients across laboratory, manufacturing, and enterprise applications. Ideal candidates will have 5+ years of experience, strong project management, and the ability to work independently in a fast‑paced environment, coordinating complex

Qualifications

• Degree in Information Technology, Life Science or Technical discipline.
• 5+ years of relevant industry experience.
• Demonstrated project management ability with good written and strong communication is required.
• Knowledge of the computerized system lifecycle activities, CSV, and IT controls in a regulated
• Detail‑oriented mindset ensuring accuracy and compliance in documentation.
• Experience successfully coordinating and navigating complex issues with internal and external
• Detail oriented and organized, ensuring accuracy at all times.
• Self starter with the ability to work independently while managing multiple validation activities in a fast‑paced environment.
• Highly motivated and proactive, able to anticipate validation needs and drive tasks to completion with minimal supervision.

Responsabilités

• Expertise with 21 CFR Part 11, Annex 11, GAMP 5, and data integrity ALCOA+.
• Complete the execution and documentation required per the CSV. This includes all CSV activities, documentation requirements and reports including plans, risk assessments, user requirements, functional requirements, specifications, data integrity assessments, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews. Scope includes direct impact laboratory, manufacturing and enterprise (multi‑site) applications.
• Experience with Agile, Waterfall, and hybrid SDLC models for regulated systems.
• 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.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform ad‑hoc duties as assigned.

Connaissances

Project management

Documentation

Communication

Regulatory compliance

Validation lifecycle

Data integrity

Attention to detail

Independent worker

Fast-paced environment

Formation

Degree in IT / Life Science / Technical

Description du poste

Iovance Biotherapeutics, Inc. is hiring a Computer Systems Validation Analyst II to support CSV lifecycle activities and ensure compliance with 21 CFR Part 11, Annex 11 and data integrity.

The role requires delivering validated computer systems for internal clients across laboratory, manufacturing, and enterprise applications. Ideal candidates will have 5+ years of experience, strong project management, and the ability to work independently in a fast‑paced environment, coordinating complex