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

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

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

1. 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.

2. Develop Validation Strategy & Risk-Based Approach

• 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.

3. Ensure Regulatory Compliance

• Ensure compliance with 21 CFR Part 11, GxP Regulations, GAMP 5, Data Integrity requirements, Data Privacy regulations, Information Security standards and SOX IT controls.
• Support audit readiness and inspection preparedness.

4. Manage Validation Deliverables

• 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.

5. Partner with Quality & Compliance Teams

• 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.

6. Support SAP Implementation Workstreams

• 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.

Basic Skills & Experience

• Minimum of 12+ 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.
• Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of SAP S4 HANA, considering GxP & Non GxP elements and recommend for risk-based testing approach as required.
• Work with the Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvements plan to streamline practices, and revise CSV related SOPs as necessary.
• 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.).
• Successful track record using Lean/Agile approaches to validate assets.
• Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments.
• Ability to pursue and grow deep client relationships.
• Provide leadership in critical engagements and drive successful outcomes.
• Preferable IT background to understand larger impact of architecture / technical complexities on the program.
• 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

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

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 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.