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LS/CON SAP Computer System Validation - Business Consulting

Infosys Ltd
  • Foster City, CA
    4 days ago
    Infosys Ltd

    Job Description

    2251736No5439237910.00.009/15/2026LS/CON SAP Computer System Validation - Business ConsultingConsultant - 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. Own and drive CSV activities for SAP ECC to SAP S/4HANA transformation programs and new SAP implementations.

    2. Ensure validation activities comply with regulatory and company quality requirements.

    3. Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs.

    4. Ensure compliance with 21 CFR Part 11, GxP Regulations, GAMP 5, Data Integrity requirements, Data Privacy regulations, Information Security standards and SOX IT controls

    5. 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

    6. Collaborate with client Quality, Compliance, and Validation teams.

    7. 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)

    Basic Skills & Experience

    • Minimum of 3+ 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
    • 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.)
    • 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.

    153671BRCaliforniaUSAInfosys Limited Associate - Business ConsultingITL USA Foster City, CA Life SciencesProcess|Consulting processes|Technology Consulting process Consultant- SAP Computerized System Validation (CSV), Life Sciences- Business Consulting84706102941

    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 a next-generation consulting partner that bridges strategy and execution. With an AI-first mindset, deep industry knowledge, and the combined strengths of business and technology consulting, it helps enterprises turn bold vision into tangible outcomes, faster, smarter, and at scale. Infosys Consulting is helping some of the world''s most recognizable brands transform and innovate. Our consultants are industry experts that lead complex change agendas driven by disruptive technology. With offices in 20 countries and backed by the power of the global Infosys brand, our teams help the C-suite navigate today''s digital landscape to win market share and create shareholder value for lasting competitive advantage.

    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.

    Numbers & Facts

    LocationFoster City, CA
    IndustryComputer/IT Services
    Company Size10,000 employees or more
    Websitehttps://www.infosys.com/careers

    About Company

    Infosys is a global leader in next-generation digital services and consulting. We enable clients in 45 countries to navigate their digital transformation.

    With over three decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.

    Skills

    • Artificial Intelligence (AI)unmatched
    • Atlassian JIRAunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Channel Strategiesunmatched
    • Cloud Computingunmatched
    • Code of Federal Regulationsunmatched
    • Communication Skillsunmatched
    • Computer Systemsunmatched
    • Consultingunmatched
    • Data Migrationunmatched
    • Data Qualityunmatched
    • ERP (Enterprise Resource Planning)unmatched
    • Financeunmatched
    • Global Brandingunmatched
    • GxPunmatched
    • Healthcare Reimbursementunmatched
    • Information/Data Security (InfoSec)unmatched
    • Life Insuranceunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Market Shareunmatched
    • Master Data Management (MDM)unmatched
    • Medical Conditionsunmatched
    • Multitaskingunmatched
    • Privacy Regulationsunmatched
    • Process Managementunmatched
    • Process Validationunmatched
    • Procurement Managementunmatched
    • Project Planningunmatched
    • Project/Program Managementunmatched
    • Quality Managementunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Requirements Managementunmatched
    • Risk Analysisunmatched
    • Risk Managementunmatched
    • SAPunmatched
    • SAP BusinessObjects Governance Risk & Compliance (GRC)unmatched
    • SAP ECC (fka SAP R/3 and SAP ERP)unmatched
    • Sarbanes-Oxley Act (SOX)unmatched
    • ServiceNowunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Supply Chainunmatched
    • System Validationunmatched
    • Team Playerunmatched
    • Technical/Engineering Designunmatched
    • Traceabilityunmatched
    • Validation Planunmatched
    • Vision Planunmatched

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