Computer Systems Validation Analyst II

About Iovance Biotherapeutics, Inc.  

Iovance Biotherapeutics, Inc.  is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com. 

Amtagvi® and its accompanying design marks, Proleukin^®, Iovance^®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. 

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com. 

Overview

The Computer Systems Validation Analyst II supports all aspects of the Computer Systems Validation (CSV) Lifecycle. This employee will create documentation, execute implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies. They should be able to work either independently or as part of a team to deliver computer system validation projects on time and within budget. They must have experience generating CSV lifecycle documentation to meet ongoing requirements such as 21CFR Part 11, EU Annex 11, and data integrity.\

Essential Functions and Responsibilities

• 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. 

Required Education, Skills, and Knowledge

• 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. 

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information. 

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines 

Work Environment 

This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

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