Senior CSV Specialist: GxP Validation & AI-Driven QA

Katalyst CRO; Lawrenceville (NJ); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO seeks an experienced CSV professional to support enterprise GxP systems in Cell Therapy projects. You will assist validation leads, ensure deliverables and testing align with the Client CSV SOP, and communicate with Business, IT, and Quality teams.

The role requires extensive pharma/biotech validation experience, strong data integrity, CSA principles, and proficiency with Qumas, SharePoint, ALM/Jira, and EDMS.

Competenze

• 8–10+ years in pharmaceutical/biotech or regulated environments.
• 5+ years applying Data Integrity/ALCOA+ in CSV contexts.
• Strong understanding of CSA principles and regulatory expectations.
• Experience with regulatory writing and document control.
• Familiarity with GMP, GLP and GAMP5 principles.
• Ability to develop, review, and approve CSV deliverables.

Mansioni

• Support creation, review, and approval of CSV deliverables for custom in-house solutions.
• Maintain communication with stakeholders to track CSV needs and compliance.
• Create documents to established standards and respond to reviews.
• Follow SOPs and industry best practices in validation activities.
• Leverage tools like EDMS, Qumas, SharePoint, ALM/Jira for documentation and lifecycle management.

Conoscenze

Data Integrity/ALCOA+

CSA principles

Technical writing

Regulatory knowledge

Cross-functional collaboration

Formazione

Bachelor's degree in Engineering/Pharma/related

Strumenti

MS Office

Visio

Qumas

SharePoint

ALM

Jira

ServiceNow

EDMS

Descrizione del lavoro

Katalyst CRO seeks an experienced CSV professional to support enterprise GxP systems in Cell Therapy projects. You will assist validation leads, ensure deliverables and testing align with the Client CSV SOP, and communicate with Business, IT, and Quality teams.

The role requires extensive pharma/biotech validation experience, strong data integrity, CSA principles, and proficiency with Qumas, SharePoint, ALM/Jira, and EDMS.