S/4HANA CSV Validation Lead – Life Sciences Expert

Infosys; Foster City (CA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Plan

401(k) plan

Paid holidays

Job summary

Infosys is seeking a senior Consultant for Computerized System Validation (CSV) leadership in Life Sciences, focusing on SAP S/4HANA validations from ECC migrations to cloud validation. The role involves risk-based validation, adherence to 21 CFR Part 11 and GxP, and cross-functional collaboration with Quality and Compliance teams.

You will coordinate validation deliverables, work with SAP modules (FI/CO, MM, QM, MDG) and ensure audit readiness while supporting client strategic SAP

Qualifications

• Lead CSV activities for SAP ECC to SAP S/4HANA transformations.
• Develop and execute validation strategies, plans, and reports for GxP and non-GxP systems.
• Ensure compliance with 21 CFR Part 11, GxP, SOX IT, and data privacy requirements.
• Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs.

Responsibilities

• Lead CSV activities for SAP ECC to S/4HANA transformations and new SAP implementations.
• Develop validation strategies, plans, protocols, and reports.
• Ensure regulatory compliance and audit readiness across projects.
• Collaborate with Quality, Compliance, and Validation teams.
• Oversee validation documentation: VP, URS, FDS, IQ/OQ/PQ, VSRs, SOPs.

Skills

CSV Leadership

SAP S/4HANA

GxP Compliance

Regulatory Knowledge

IQ/OQ/PQ

Audit Readiness

Agile/Waterfall

ServiceNow/JIRA

Data Integrity

SOX IT Controls

Tools

Solution Manager

CHARM

SAP GRC

DRC

SAP MDG

SNP/ADM

SAP Rise

Job description

Infosys is seeking a senior Consultant for Computerized System Validation (CSV) leadership in Life Sciences, focusing on SAP S/4HANA validations from ECC migrations to cloud validation. The role involves risk-based validation, adherence to 21 CFR Part 11 and GxP, and cross-functional collaboration with Quality and Compliance teams.

You will coordinate validation deliverables, work with SAP modules (FI/CO, MM, QM, MDG) and ensure audit readiness while supporting client strategic SAP