Remote CSV Analyst II: Validation & Compliance Specialist

Iovance Biotherapeutics, Inc.; United States; On-site; USD 120,000 - 135,000; Full time

Job summary

Iovance Biotherapeutics, Inc. is seeking a Computer Systems Validation Analyst II to support all aspects of the CSV lifecycle. This role ensures 21 CFR Part 11, Annex 11, and data integrity compliance, delivering high-quality documentation and validation activities.

The ideal candidate has 5+ years of relevant experience, strong project management, and the ability to work independently or within teams to meet timelines and budgets in a regulated environment.

Qualifications

• Experience with CSV lifecycle activities and IT controls in regulated environments.
• Strong written and verbal communication skills are required.
• Knowledge of 21 CFR Part 11, Annex 11, and data integrity is essential.

Responsibilities

• Create CSV lifecycle documentation and validation plans.
• Execute validation tasks and support escalation management.
• Coordinate with internal and external stakeholders across multiple sites.

Skills

Regulatory compliance

Project management

Documentation

Communication

CSV lifecycle

Education

Bachelor's degree in IT or Life Sciences

Job description

Iovance Biotherapeutics, Inc. is seeking a Computer Systems Validation Analyst II to support all aspects of the CSV lifecycle. This role ensures 21 CFR Part 11, Annex 11, and data integrity compliance, delivering high-quality documentation and validation activities.

The ideal candidate has 5+ years of relevant experience, strong project management, and the ability to work independently or within teams to meet timelines and budgets in a regulated environment.