Principal– SAP Computerized System Validation (CSV), Life Sciences- Business Consulting

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.

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.

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.

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

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.

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.

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.

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.