Senior CSV Analyst II - Regulated Systems, Life Sciences

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); Remote; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Iovance Biotherapeutics, Inc. is seeking a Computer Systems Validation Analyst II to support all aspects of the CSV lifecycle, ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity.

The role involves creating documentation, executing implementation tasks, and managing validation work across laboratory, manufacturing, and enterprise applications. The ideal candidate will have a Degree in Information Technology, Life Science or a technical field plus 5+ years of relevant

Qualifikationen

• Bachelor-level degree or higher in Information Technology, Life Science or a technical field.
• Minimum 5+ years of relevant industry experience.
• Demonstrated project management ability with strong written and verbal communication.

Aufgaben

• Lead CSV lifecycle activities, including documentation, testing, and validation.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and data integrity (ALCOA+).
• Coordinate multiple validation activities across labs, manufacturing and enterprise systems.
• Manage change controls, risk assessments, and traceability matrices.
• Support internal clients with timely delivery of validated computer systems.

Kenntnisse

Project management

Strong communication

Independent work

Ausbildung

Degree in Information Technology, Life Science or Technical discipline

Jobbeschreibung

Iovance Biotherapeutics, Inc. is seeking a Computer Systems Validation Analyst II to support all aspects of the CSV lifecycle, ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity.

The role involves creating documentation, executing implementation tasks, and managing validation work across laboratory, manufacturing, and enterprise applications. The ideal candidate will have a Degree in Information Technology, Life Science or a technical field plus 5+ years of relevant