SAP Validation Lead

Company : Katalyst HealthCares & Life Sciences

Location : Foster City, CA, 94404

Posted Date : 11 October 2025

Job Details

Job Description:

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.

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.

Requirements:

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.