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%
Industry: Life Sciences
Experience leading validation activities for large-scale SAP implementations or transformations.
Strong documentation and project leadership skills.
Required Experience: SAP, CSV, GxP Validation, Customer-Facing Leadership Skills
Job Description
We are seeking an experienced CSV (Computer System Validation) Workstream Lead to support a life sciences client in Ohio. The ideal candidate will lead CSV activities for SAP-related initiatives, ensuring compliance with regulatory requirements and validation standards throughout the project lifecycle.
Key Responsibilities
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 Qualifications
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.
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