Computer Systems Validation Analyst II

Job not on LinkedIn

🔥 3 hours ago

🇺🇸 United States – Remote

💵 $120k - $135k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Analyst

👻 Ghost score 0%

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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.

📋 Description

• Support all aspects of the Computer Systems Validation lifecycle. • Create CSV lifecycle documentation and execute implementation tasks. • Prioritize work and support escalation management activities. • Ensure compliance with regulatory requirements, including 21 CFR Part 11, EU Annex 11, and data integrity. • Complete CSV activities and documentation, including plans, risk assessments, user requirements, functional requirements, specifications, data integrity assessments, testing, change controls, traceability matrices, qualification protocols, validation reviews, and compliance reviews. • Support validation of direct-impact laboratory, manufacturing, and enterprise multi-site applications. • Respond to management, end-user, and client inquiries and provide frequent status updates. • Collaborate to deliver validated computer systems to internal clients on time and within budget. • Implement assigned change-control action items. • Manage periodic reviews of computerized systems and data integrity/data quality. • Perform ad hoc duties as assigned.

🎯 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. • Knowledge of computerized system lifecycle activities, CSV, and IT controls in a regulated environment. • Expertise with 21 CFR Part 11, Annex 11, GAMP 5, and data integrity ALCOA+. • Experience with Agile, Waterfall, and hybrid SDLC models for regulated systems. • Detail-oriented and organized, ensuring accuracy and compliance in documentation. • Ability to work independently while managing multiple validation activities in a fast-paced environment. • Ability to anticipate validation needs and drive tasks to completion with minimal supervision. • Must be able to remain standing or sitting for prolonged periods. • Must be able to move about inside an office and occasionally lift, carry, push, pull, or move up to 10 pounds. • Must have visual acuity for preparing and analyzing data, viewing computer screens, and extensive reading. • Ability to perform repetitive wrist, hand, and finger movements. • Ability to communicate with others to exchange information.