SAP CSV; Computer System Validation Workstream Lead

Overview

Job Title: SAP CSV (Computer System Validation) Workstream Lead

Location:
Ohio (Travel up to 50%)

Duration: 6 Months (with potential for long-term extension)

Travel:
Up to 50%

• Lead and manage the Computer System Validation (CSV) workstream for SAP implementations and enhancements.
• Develop, review, and approve validation deliverables, including validation plans, risk assessments, test protocols, and summary reports.
• Ensure compliance with applicable GxP, FDA, and life sciences regulatory requirements.
• Collaborate with business stakeholders, IT teams, quality assurance, and project leadership to drive validation activities.
• Provide status updates, identify risks, and ensure timely completion of CSV deliverables.
• Support audits and inspections as needed.

• Required Experience:
  
  SAP, CSV, GxP Validation, Customer-Facing Leadership Skills
• Proven experience as a CSV Lead or CSV Workstream Lead in regulated life sciences environments.
• Hands-on experience supporting SAP projects for life sciences customers.
• Strong understanding of GxP, FDA, and industry validation requirements.
• Excellent customer-facing, communication, and stakeholder management skills.
• Ability to work effectively with cross-functional teams and executive stakeholders.