Computer Systems Validation Analyst II

Iovance Biotherapeutics, Inc.

. Support all aspects of the Computer Systems Validation lifecycle.

Posted 10/16/2026full-timeRemote • United StatesMid-LevelSenior💰 $120,000 - $135,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computer Systems Validation (CSV) lifecycle management, ensuring compliance with regulatory standards such as 21 CFR Part 11 and EU Annex 11. Proficient in project management and documentation accuracy within a fast-paced, regulated environment.

Highest-signal resume keywords

Computer Systems Validation (CSV)21 CFR Part 11 ComplianceProject ManagementAgile and Waterfall SDLC ModelsData Integrity ALCOA+

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CSV Lifecycle DocumentationRisk AssessmentsFunctional RequirementsValidation ReviewsChange ControlsTraceability MatricesQualification ProtocolsTestingCompliance ReviewsData Integrity Assessments

Soft Skills

Strong CommunicationDetail-OrientedOrganizational SkillsAbility to Work IndependentlyAnticipation of Validation Needs

Industry Keywords

Regulated EnvironmentGAMP 5Computerized System Lifecycle ActivitiesMulti-Site ApplicationsEscalation Management

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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

What you’ll need

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.