About this role
LS/Principal– SAP Computerized System Validation (CSV)
Job Description: Principal– SAP Computerized System Validation (CSV), Life Sciences- Business Consulting 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. Key Responsibilities 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. Basic Skills & Experience • 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 Required Skills & Experience • 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. Key Responsibilities 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. Basic Skills & Experience • 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 • 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. Infosys is unable to provide immigration sponsorship for this role at this time
• Location: Foster City, California Required Skills & Experience • 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.
a { text-decoration: none; color: #464feb; } tr th, tr td { border: 1px solid #e6e6e6; } tr th { background-color: #f5f5f5; }
EEO/About Us: Benefits Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits:
• Medical/Dental/Vision/Life Insurance • Long-term/Short-term Disability • Health and Dependent Care Reimbursement Accounts • Insurance (Accident, Critical Illness , Hospital Indemnity, Legal) • 401(k) plan and contributions dependent on salary level • Paid holidays plus Paid Time Off About Us Infosys Consulting is the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world’s top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants: • Ability to design and implement end-to-end solutions at scale • A flat organization structure with direct access to our senior-most leaders • An entrepreneurial environment full of bright, highly motivated consultants • Opportunities for motivated consultants to impact local communities • The ability to design your career and drive your professional learning and development • A truly global culture
EEO Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.