[Hiring] Computer Systems Validation Analyst II @Iovance Biotherapeutics

Role Description

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, including:
  • All CSV activities
  • Documentation requirements and reports
  • 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.
• Provide 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.

Qualifications

• 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 skills.
• 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.
• Highly motivated and proactive, able to anticipate validation needs and drive tasks to completion with minimal supervision.

Requirements

• 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.

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.

Pay Transparency

The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience, and skills.

• $120,000 — $135,000 USD

Company Description

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.