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

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

Consultant – SAP S/4HANA Validation Lead (Life Sciences)

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.

Consultant – SAP S/4HANA Validation Lead (Life Sciences)

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

• Own and drive CSV activities for SAP ECC to SAP S/4HANA transformation programs and new SAP implementations.
• Ensure validation activities comply with regulatory and company quality requirements.
• Define validation frameworks and lifecycle methodologies for SAP S/4HANA programs.
• 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.
• 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)

Basic Skills & Experience

Required Skills & Experience

• Minimum of 3+ years of professional experience in Life Sciences industry working for a consulting services organization and/or industry experience.
• Experience creating, reviewing and approving / acknowledging validation deliverables.
• Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Cloud, S4, Data Privacy, Data Integrity and Information Security
• Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.
• Knowledge on basic function on SAP workstreams/modules
• Knowledge of various tools/applications used in SAP implementation program Like Solution Manager, CHARM, SAP GRC, DRC, SAP MDG, SAP Rise, Data migration tool (SNP, ADM etc.)
• 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
• 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

• 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 a next-generation consulting partner that bridges strategy and execution. With an AI-first mindset, deep industry knowledge, and the combined strengths of business and technology consulting, it helps enterprises turn bold vision into tangible outcomes, faster, smarter, and at scale. Infosys Consulting is helping some of the world's most recognizable brands transform and innovate. Our consultants are industry experts that lead complex change agendas driven by disruptive technology. With offices in 20 countries and backed by the power of the global Infosys brand, our teams help the C-suite navigate today's digital landscape to win market share and create shareholder value for lasting competitive advantage.

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.