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

Key Responsibilities

• Develop Validation Strategy & Risk-Based Approach
• Ensure Regulatory Compliance
• Manage Validation Deliverables
• Partner with Quality & Compliance Teams
• Support SAP Implementation Workstreams

Basic Skills & Experience Required

• 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.
• 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.

Minimum of 12+ Years of Professional Experience

• Involvement in leading 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.

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

• Competitive pay
• 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.