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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Principal- SAP Computerized System Validation (CSV) - **Company:** Infosys - **Location:** Foster City, CA, United States - **Contract:** Permanent contract - **Skills:** Agile Methodology, JIRA, Cloud Computing, Cyber Security, System Configuration, Data Governance, Data Integrity, Data Migration, SAP ERP, Systems Development Life Cycle, SAP (Applications), SAP FI/CO, SAP GRC, SAP HANA, SAP Implementation, Software Engineering, System Testing, Strategies of Testing, Iq/oq/pq, IT General Controls (ITGC), RISE with SAP, Information Technology, SAP S/4HANA, SAP MDG, Veeva, GXP, Servicenow - **Published:** August 26, 2026 - **Apply:** https://sjobs.brassring.com/TGnewUI/Search/home/HomeWithPreLoad?partnerid=25633&siteid=5439&PageType=JobDetails&jobid=2250809 ## About the Role We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for ERP applications like ECC/SAP S/4 HANA, Cloud Validation, Risk management and Quality Management. The candidate will have to perform validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation program., * Minimum of 12+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience. * Experience creating, reviewing and approving / acknowledging validation deliverables. * Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements * Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Cloud, S4, Data Privacy, Data Integrity and Information Security * Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of SAP S4 HANA, considering GxP & Non GxP elements and recommend for risk-based testing approach as required. * Work with the Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvements plan to streamline practices, and revise CSV related SOPs as necessary. * Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones. * Knowledge on basic function on SAP workstreams/modules * Knowledge of various tools/applications used in SAP implementation program Like Solution Manager, CHARM, SAP GRC, DRC, SAP MDG, SAP Rise, Data migration tool (SNP, ADM etc.) * Successful track record using Lean/Agile approaches to validate assets * Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments * Ability to pursue and grow deep client relationships * Provide leadership in critical engagements and drive successful outcomes * Preferable IT background to understand larger impact of architecture / technical complexities on the program * Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time * Location: Foster City, California, * Strong understanding of pharmaceutical compliance regulations and validation concepts. * Experience with Agile and Waterfall methodologies. * Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM. * Ability to manage multiple projects and adapt to complex environments. * IT background preferred to understand program complexities. * Excellent communication and collaboration skills. Principal Consultant - SAP S/4HANA Validation Lead (Life Sciences) We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation for ERP applications like ECC/SAP S/4 HANA, Cloud Validation, Risk management and Quality Management. The candidate will have to perform validation service activities related to ECC to SAP S/4 HANA transformation or SAP implementation program., * Minimum of 12+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience. * Experience creating, reviewing and approving / acknowledging validation deliverables. * Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements * Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Cloud, S4, Data Privacy, Data Integrity and Information Security * Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of SAP S4 HANA, considering GxP & Non GxP elements and recommend for risk-based testing approach as required., * Strong understanding of pharmaceutical compliance regulations and validation concepts. * Experience of having led large S/4 HANA transformation programs from a Validation Lead perspective Experience with Agile and Waterfall methodologies. * Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM. * Ability to manage multiple projects and adapt to complex environments. * IT background preferred to understand program complexities. * Excellent communication and collaboration skills. ## Description 1. Lead Computerized System Validation (CSV) Activities * Own and drive CSV activities for SAP ECC to SAP S/4HANA transformation programs and new SAP implementations. * Develop and execute validation strategies, plans, protocols, and reports for GxP and non-GxP systems. * Ensure validation activities comply with regulatory and company quality requirements. 2. Develop Validation Strategy & Risk-Based Approach * Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs. * Conduct system risk assessments and determine validation scope. * Implement risk-based testing approaches aligned with GAMP 5 and industry best practices. 3. Ensure Regulatory Compliance * Ensure compliance with 21 CFR Part 11, GxP Regulations, GAMP 5, Data Integrity requirements, Data Privacy regulations, Information Security standards and SOX IT controls * Support audit readiness and inspection preparedness. 4. Manage Validation Deliverables * Create, review, approve, and maintain-Validation Plans (VP), User Requirements Specifications (URS), Functional & Design Specifications, Risk Assessments, IQ/OQ/PQ documents, Traceability Matrices, Validation Summary Reports (VSR) and SOPs and related quality documents 5. Partner with Quality & Compliance Teams * Collaborate with client Quality, Compliance, and Validation teams. * Ensure systems comply with internal policies and health authority requirements. * Recommend process improvements and updates to CSV procedures and SOPs. 6. Support SAP Implementation Workstreams * Work closely with SAP functional and technical teams across modules such as: Finance (FI/CO), Supply Chain, Manufacturing, Procurement, Quality Management and Master Data Governance (MDG) * Assess validation impact of system configuration, enhancements, interfaces, and data migration activities., * Work with the Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvements plan to streamline practices, and revise CSV related SOPs as necessary. * Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones. * Knowledge on basic function on SAP workstreams/modules * Knowledge of various tools/applications used in SAP implementation program Like Solution Manager, CHARM, SAP GRC, DRC, SAP MDG, SAP Rise, Data migration tool (SNP, ADM etc.) * Successful track record using Lean/Agile approaches to validate assets * Provide leadership in critical engagements and drive successful outcomes * Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. 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