Job Title: CSV Specialists (2 Roles) – W2/C2C/1099
Location: NY
Start Date: Mid November
Duration: 6 months to start plus extensions
Work Schedule: Onsite
JOB DESCRIPTION:
The company was recently bought and currently integrating systems, having experience with CSV integration is a must. Responsible for managing end-to-end CSV deliverables for both new & existing applications like Blue Mountain RAM and Veeva. Help support the existing and new projects.
Must-Have Requirements:
- Minimum of 10+ years of experience in Computer System Validation (CSV), with a strong emphasis on system integration.
- Proven experience with Blue Mountain RAM and Veeva applications.
- Strong project management skills focused on CSV and regulatory compliance.
Key Responsibilities:
- Manage the end-to-end CSV process for integrating both legacy and new systems.
- Conduct initial risk assessments to ensure compliance and identify potential risks.
- Revise and configure existing systems to meet the new company's standards and requirements.
- Oversee system installations, data execution, and PQ (Performance Qualification) execution.
- Manage Veeva change controls for new implementations and system updates.
- Develop and execute validation plans, including installations and data verification tests.
- Ensure systems are fully validated and prepared for new system releases.
- Create and maintain Validation Summary Reports (VSR) for all integrated systems.
- Coordinate project timelines, adjusting schedules and due dates as needed to meet project goals.
