SAP Validation Lead

Foster, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.

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 s...

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.