CSV Lead

Katalyst CRO; Raritan (NJ); In loco; USD 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking an experienced Validation professional to lead end-to-end validation lifecycles in the pharmaceutical/biotech/medical device sector from its New Jersey operations. You will oversee Inventory, Assessment, Remediation, and Final Disposition while performing ERP, data migration, and cloud validation activities.

The role requires preparing IQ/OQ/PQ and traceability documentation, ensuring compliance with GxP and FDA regulations, and supporting acquisitions or divestitures.

Competenze

• Proven experience leading validated systems projects in life sciences.
• Strong ability to communicate with diverse stakeholders and drive validation lifecycle.
• Experience with CSV and GxP/FDA regulations is required.

Mansioni

• Manage end-to-end validation lifecycle (Inventory, Assessment, Remediation, Final Disposition).
• Perform ERP validation, Data Migration, and Cloud Validation activities.
• Prepare and review validation documentation (Validation Plans, IQ/OQ/PQ, Traceability Matrix, Reports, SOPs).
• Ensure compliance with GxP, FDA regulations, and risk-based validation.
• Support Acquisitions, Divestitures, and Business Separation projects.
• Demonstrate strong leadership and stakeholder communication.

Conoscenze

Leadership

Stakeholder communication

Validation expertise

Strumenti

IQ/OQ/PQ

Descrizione del lavoro

• Manage end-to-end validation lifecycle (Inventory, Assessment, Remediation, Final Disposition)
• Perform ERP validation, Data Migration, and Cloud Validation activities
• Prepare and review validation documentation (Validation Plans, IQ/OQ/PQ, Traceability Matrix, Reports, SOPs)
• Ensure compliance with GxP, FDA regulations, and risk-based validation
• Support Acquisitions, Divestitures, and Business Separation projects
• Demonstrate strong leadership and stakeholder communication

Roles & Responsibilities

• Manage end-to-end validation lifecycle (Inventory, Assessment, Remediation, Final Disposition)
• Perform ERP validation, Data Migration, and Cloud Validation activities
• Prepare and review validation documentation (Validation Plans, IQ/OQ/PQ, Traceability Matrix, Reports, SOPs)
• Ensure compliance with GxP, FDA regulations, and risk-based validation
• Support Acquisitions, Divestitures, and Business Separation projects
• Demonstrate strong leadership and stakeholder communication

Experience

• 710+ years of experience in Computer System Validation (CSV)
• Experience in Pharmaceutical / Biotechnology / Medical Device industry