Katalyst CRO
SAP Validation Lead
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SAP Validation Lead
role at
Katalyst CRO
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.
Responsibilities
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.
Author, review, and approve URS, FRS, Risk Assessments, Validation Plans, Test Scripts, and Reports.
Conduct impact assessments, risk evaluations, and periodic system reviews.
Lead Change Control assessments for SAP updates, patches, and customizations.
Ensure incident management, deviations tracking, and CAPA resolution.
Partner with Business, IT, and QA teams to align validation with business needs.
Act as the SAP Validation SME during internal and external audits.
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.
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
Get notified about new SAP Lead jobs in
Foster City, CA .
#J-18808-Ljbffr
SAP Validation Lead
role at
Katalyst CRO
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.
Responsibilities
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.
Author, review, and approve URS, FRS, Risk Assessments, Validation Plans, Test Scripts, and Reports.
Conduct impact assessments, risk evaluations, and periodic system reviews.
Lead Change Control assessments for SAP updates, patches, and customizations.
Ensure incident management, deviations tracking, and CAPA resolution.
Partner with Business, IT, and QA teams to align validation with business needs.
Act as the SAP Validation SME during internal and external audits.
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.
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
Get notified about new SAP Lead jobs in
Foster City, CA .
#J-18808-Ljbffr