LSPrincipal– SAP Computerized System Validation (CSV)
Job Location:
Foster, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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.
- 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.
- 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 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
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.
- 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.
- 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 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.
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 worlds 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.
About Company
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