Lead SAP S/4HANA CSV Consultant – Life Sciences

Infosys; Foster City (CA); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Medical/Dental/Vision/Life Insurance

Long-term/Short-term Disability

Health and Dependent Care Reimburse- m

Insurance (Accident, Critical Illness,

401(k) plan

Paid holidays + PTO

Job summary

Infosys Consulting in Foster City, CA, seeks a Consultant – SAP S/4HANA Validation Lead (Life Sciences) to drive CSV activities for SAP ERP transformations and implementations. You will ensure compliance with 21 CFR Part 11, GxP, and data integrity, develop validation plans, and manage IQ/OQ/PQ documents across SAP modules.

Collaboration with Quality, Compliance, and Validation teams is required. Experience in agile/waterfall, ServiceNow/JIRA tools, and leading large S/4HANA validation programs

Qualifications

• 3+ years in Life Sciences industry (consulting or in-house)
• Experience creating/approving validation deliverables
• Knowledge of risk management and quality requirements for IT projects
• Understanding of 21 CFR Part 11, GxP, GAMP 5, SOX IT, data privacy/integrity
• Led SAP S/4HANA validation programs from a Lead perspective
• Experience with Agile and Waterfall methodologies

Responsibilities

• Own and drive CSV activities for SAP ECC to SAP S/4HANA transformations or SAP implementations
• Ensure validation activities comply with regulatory and company quality requirements
• Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs
• Maintain documentation (VP, URS, FSD, IQ/OQ/PQ, TRMs, VSRs, SOPs)
• Collaborate with client Quality, Compliance, and Validation teams
• Work with SAP modules (FI/CO, QM, MDG, etc.) across projects

Skills

Life Sciences experience

Validation deliverables

Risk management

Communication

Agile and Waterfall

Regulatory awareness

Tools

ServiceNow

JIRA

Veeva

HPALM

SAP Solution Manager

CHARM

SAP GRC

DRC

SAP MDG

Data migration tools (SNP, ADM)

Job description

Infosys Consulting in Foster City, CA, seeks a Consultant – SAP S/4HANA Validation Lead (Life Sciences) to drive CSV activities for SAP ERP transformations and implementations. You will ensure compliance with 21 CFR Part 11, GxP, and data integrity, develop validation plans, and manage IQ/OQ/PQ documents across SAP modules.

Collaboration with Quality, Compliance, and Validation teams is required. Experience in agile/waterfall, ServiceNow/JIRA tools, and leading large S/4HANA validation programs