Remote CSV Analyst II: Regulatory Compliance and Validation

Wwshemi; United States; Remote; USD 120,000 - 135,000; Full time

Job summary

Iovance Biotherapeutics is seeking a Computer Systems Validation Analyst II to support the CSV lifecycle across laboratory, manufacturing, and enterprise applications. The role emphasizes compliance with 21 CFR Part 11, EU Annex 11, and data integrity, with tasks spanning documentation, risk assessments, and traceability.

Remote work option is available; you will collaborate with internal teams and external partners, manage validation activities, and ensure on-time delivery within budget while

Qualifications

• Degree in Information Technology, Life Science or Technical discipline.
• 5+ years of relevant industry experience.
• Strong written and verbal communication skills.
• Knowledge of the CSV lifecycle activities, CSV, and IT controls in a regulated environment.
• Detail-oriented mindset ensuring accuracy and compliance in documentation.
• Experience coordinating with internal and external stakeholders.
• Self-starter who can work independently while managing multiple validation activities.

Responsibilities

• Create documentation, execute implementation tasks and support escalation management to ensure CSV compliance.
• Execute CSV activities including plans, risk assessments, user requirements, functional specs, data integrity assessments, testing, change controls, traceability, validation and reviews.
• Ensure compliance with 21 CFR Part 11, EU Annex 11 and data integrity ALCOA+.
• Work collaboratively to deliver validated computer systems for internal clients.
• Support periodic reviews and change controls for computerized systems.

Skills

Project management

Communication

Attention to detail

Independent work

Problem solving

Education

Degree in Information Technology or Life Science

Job description

Iovance Biotherapeutics is seeking a Computer Systems Validation Analyst II to support the CSV lifecycle across laboratory, manufacturing, and enterprise applications. The role emphasizes compliance with 21 CFR Part 11, EU Annex 11, and data integrity, with tasks spanning documentation, risk assessments, and traceability.

Remote work option is available; you will collaborate with internal teams and external partners, manage validation activities, and ensure on-time delivery within budget while