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 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.
Principal 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
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
- 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
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.
