SAP Validation Lead(CSV) - Foster City, CA/Raleigh, NC - No OPT/CPT - 10+ years
suhel ahmad
Title – SAP Validation Lead
Location: Foster City, CA or Raleigh, NC
Employment Type : Contract
Experience: 10+ Years
No OPT/CPT
Job Summary
- We are seeking an experienced SAP Validation Lead to drive Computer System Validation (CSV) efforts for SAP systems in a regulated environment.
- The ideal candidate will ensure SAP implementations and enhancements comply with GxP, FDA 21 CFR Part 11, Annex 11, and industry validation standards.
- This role requires deep expertise in SAP validation, SDLC methodologies, risk-based validation approaches, and change management processes.
- You will collaborate closely with Business, IT, QA, and Regulatory stakeholders to ensure compliance, system integrity, and data reliability.
Key Responsibilities
✔ SAP System Validation & Compliance
Lead end-to-end validation of SAP systems in line with GxP, 21 CFR Part 11, Annex 11, and ALCOA+ principles.
Develop and execute validation strategies, IQ, OQ, PQ protocols, and test scripts.
Ensure documentation aligns with GAMP 5, FDA, and industry standards.
✔ Validation Documentation & Risk Assessment
Author, review, and approve URS, FRS, Risk Assessments, Validation Plans, Test Scripts, and Reports.
Conduct impact assessments, risk evaluations, and periodic system reviews.
✔ Change Control & Incident Management
Lead Change Control assessments for SAP updates, patches, and customizations.
Ensure incident management, deviations tracking, and CAPA resolution.
✔ Collaboration & Stakeholder Management
Partner with Business, IT, and QA teams to align validation with business needs.
Act as the SAP Validation SME during internal and external audits.
✔ System Decommissioning & Lifecycle Management
Oversee system decommissioning with full compliance and documentation.
Drive continuous improvement for validation processes.
Required Qualifications & Skills
- 8+ years in SAP validation, compliance, and CSV within Pharma, Life Sciences, or Medical Devices.
- Strong knowledge of SAP ECC, S/4HANA, SAP GxP, SAP QM, SAP MM, SAP WM.
- Expertise in validation deliverables (URS, FRS, IQ, OQ, PQ, Validation Reports).
- Experience with GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+ compliance.
- Hands-on with change management, incident tracking, and system reviews.
- Strong understanding of data integrity, security controls, and electronic record-keeping.
- Excellent documentation skills with Good Documentation Practices (GDP).
- Strong problem-solving, communication, and stakeholder engagement abilities.
✨ Join us to lead validation initiatives that ensure compliance, system reliability, and operational excellence in a highly regulated environment.
Sr Techincal Recruiter
UpStream Global Services (a division of Software Pundits Inc - " Since 1989 ")
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