Computer Systems Validation Analyst II

November 20

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Iovance Biotherapeutics, Inc.

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Supports all aspects of the Computer Systems Validation (CSV) Lifecycle. • Creates documentation and executes implementation tasks while ensuring compliance with regulatory agencies. • Generates CSV lifecycle documentation to meet ongoing requirements such as 21 CFR Part 11, EU Annex 11, and data integrity. • Completes execution and documentation required per the CSV, including plans, risk assessments, user requirements, functional requirements, and validation reviews. • Ensures project deadlines and performance standards are met while responding to inquiries from management, end users, and clients. • Collaboratively works to deliver validated computer systems for internal clients.

🎯 Requirements

• 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 environment. • Detail-oriented mindset ensuring accuracy and compliance in documentation. • Experience successfully coordinating and navigating complex issues with internal and external stakeholders. • Self starter with the ability to work independently while managing multiple validation activities in a fast-paced environment.

🏖️ Benefits

• Reasonable accommodations may be made upon request to enable individuals to perform essential functions. • Employee workspace is expected to be safe and free from hazards. • Equal-opportunity employer commitments.