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.

2. Develop Validation Strategy & Risk-Based Approach

3. Ensure Regulatory Compliance

4. Manage Validation Deliverables

5. Partner with Quality & Compliance Teams

6. Support SAP Implementation Work streams

• Lead Computerized System Validation (CSV) Activities
• Own and drive CSV activities for SAP ECC to SAP S/4
  
  HANA 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.
• Define validation frameworks and lifecycle methodologies for SAP S/4
  
  HANA programs.
• Conduct system risk assessments and determine validation scope.
• Implement risk-based testing approaches aligned with GAMP 5 and industry best practices.
• 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.
• 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.
• Ensure systems comply with internal policies and health authority requirements.
• Recommend process improvements and updates to CSV procedures and SOPs.
• 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.
• 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 work streams/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
• Provide leadership in critical engagements and drive successful outcomes
• 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 with Agile and Waterfall methodologies.
• Familiarity with tools like Service Now, 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.

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.

2. Develop Validation Strategy & Risk-Based Approach

3. Ensure Regulatory Compliance

4.…