CSV Engineer

Role : CSV Engineer

Rate : $40 / hr. C2C

Location : Onsite in Warren, NJ

Visa : ny visa

Duration : 12+ month

Client : Verista

We are seeking a skilled Computer System Validation (CSV) Specialist to support the commissioning and qualification (C&Q) efforts for a cell therapy manufacturing project. This role ensures that computer systems meet regulatory compliance standards and are validated to facilitate product manufacturing.

Responsibilities Include :

• Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment
• Collaborate closely with automation and validation teams to ensure systems meet project and regulatory compliance standards
• Manage the document lifecycle, including creation, revision, and storage, in compliance with project documentation systems
• Participate in weekly project meetings to coordinate with system owners and management for alignment on project needs and issue resolution
• Conduct risk assessments and generate compliance reports, managing deviations and ensuring all required documentation meets quality and regulatory standards
• Oversee vendor interactions, including reviewing and tracking vendor deliverables and system qualifications

Requirements :