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

Infosys; Foster City (CA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical/Dental/Vision/Life Insurance

Long-term/Short-term Disability

401(k) plan

Job summary

Infosys Consulting in the United States is seeking a Consultant – SAP S/4HANA Validation Lead for Life Sciences to drive CSV activities across ECC to SAP S/4HANA transformations and new SAP implementations.

You will define validation frameworks, ensure compliance with 21 CFR Part 11, GxP and data integrity, and collaborate with client Quality, Compliance and Validation teams while coordinating with SAP modules like FI/CO, QM, MDG. This full-time role is based in Foster City, CA.

Qualifications

• Minimum 3+ years in Life Sciences with consulting or industry experience.
• Experience creating, reviewing and approving validation deliverables.
• Knowledge of risk management and quality requirements for IT projects.
• Understanding of 21 CFR Part 11, GxP, GAMP 5, SOX IT, Cloud and Data Privacy.
• Ability to build integrated CSV project plans with validation deliverables.
• Familiar with SAP workstreams/modules.
• Authorized to work in the US without visa sponsorship.

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, Data Privacy and SOX IT controls.
• Create, review, approve, and maintain VP, URS, FDS/Design Specs, Risk Assessments, IQ/OQ/PQ, VSRs and SOPs.
• Collaborate with client Quality, Compliance, and Validation teams.
• Work with SAP teams across FI/CO, SCM, QM, MDG; manage multiple projects.

Skills

Project management

Regulatory compliance

Life Sciences experience

Validation deliverables

Tools

Solution Manager

CHARM

SAP GRC

DRC

MDG

SAP Rise

Data migration tools

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.

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

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 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.