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

• 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.

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.