SAP S/4HANA Validation SME

CornerStone Technology Talent Services
CornerStone Technology Talent Services

Posted on Sep 22, 2026
SAP S/4HANA Validation SME – Life Sciences Hybrid 3 days a week: Foster City, CA
CornerStone Technology Talent Services is seeking an experienced SAP S/4HANA Validation SME to support a large-scale enterprise transformation within the Life Sciences industry.

This is a highly visible consulting opportunity for a senior validation professional who combines deep Computer System Validation (CSV) expertise with hands-on knowledge of SAP S/4HANA implementations in regulated GxP environments.

The ideal candidate has spent significant time supporting complex pharmaceutical or Life Sciences technology programs and understands how to develop and execute risk-based validation strategies across the full software development lifecycle.
What You’ll Do

  • Serve as a Validation SME supporting a global SAP S/4HANA transformation.

  • Develop and document the overall Computer System Validation strategy for SAP implementation activities.

  • Define validation approaches across both GxP and non-GxP systems and processes.

  • Create, review, approve and oversee validation lifecycle documentation and deliverables.

  • Develop risk-based validation and testing strategies aligned with regulatory and internal quality requirements.

  • Ensure SAP implementation activities comply with applicable company policies, quality standards and health authority regulations.

  • Partner closely with Quality, Compliance, IT, SAP functional teams, project management and business stakeholders.

  • Incorporate required CSV lifecycle deliverables, quality gates and validation milestones into integrated project plans.

  • Evaluate system changes and determine appropriate validation requirements based on risk, functionality and regulatory impact.

  • Review existing validation processes and recommend opportunities to improve or streamline CSV practices.

  • Support development and revision of CSV-related SOPs, procedures and standards.

  • Provide validation leadership during critical project phases and help drive issues through resolution.

  • Communicate validation risks, requirements and recommendations to both technical and executive stakeholders.
What We’re Looking For Required Experience

  • Approximately 12+ years of professional experience, with substantial experience supporting technology initiatives within Life Sciences, pharmaceutical, biotechnology or another highly regulated environment.

  • Extensive hands-on experience with Computer System Validation (CSV).

  • Demonstrated experience validating SAP enterprise applications, ideally including both SAP ECC and SAP S/4HANA.

  • Experience supporting major SAP S/4HANA implementation, migration or transformation programs.

  • Strong knowledge of:

    • GxP

    • 21 CFR Part 11

    • GAMP 5

    • Computerized System Validation

    • Data Integrity

    • Risk Management

    • Quality Management Systems

    • SDLC controls

    • SOX IT controls

    • Data Privacy

    • Information Security

  • Experience creating, reviewing and approving validation documentation throughout the system lifecycle.

  • Strong understanding of risk-based validation and testing methodologies.

  • Ability to distinguish validation requirements for GxP versus non-GxP functionality.

  • Experience working within formal pharmaceutical Quality and Compliance frameworks.

  • Strong written and verbal communication skills, including the ability to present validation strategy and risk to senior stakeholders.
SAP Knowledge
Candidates should understand the broader SAP implementation ecosystem and how validation activities interact with SAP technology and functional workstreams.

Experience with several of the following is highly desirable:

  • SAP S/4HANA

  • SAP ECC

  • SAP Solution Manager

  • SAP ChaRM

  • SAP GRC

  • SAP MDG

  • SAP RISE

  • SAP DRC

  • SAP data migration

  • SAP master data processes

  • SAP functional workstreams

  • Enterprise integration and system architecture

Experience with SAP migration technologies or platforms used during enterprise transformation programs is also valuable.
Additional Qualifications
The strongest candidates will bring:

  • Experience leading validation activities across large, global SAP programs.

  • Consulting experience supporting enterprise Life Sciences clients.

  • Experience operating within Agile or Lean delivery environments while maintaining regulated validation requirements.

  • Strong stakeholder-management skills across Quality, Technology and business organizations.

  • Ability to manage multiple workstreams and priorities within a complex transformation program.

  • Strong client-facing presence and the ability to build trusted relationships with senior stakeholders.

  • An IT or technical background that provides an understanding of architecture, integrations, infrastructure and the downstream impact of technical decisions on validation.

  • Ability to provide leadership during high-risk or high-visibility phases of an implementation.
Work Environment
This is a hybrid opportunity based in Foster City, California, requiring onsite work three days per week.

The engagement is expected to be long-term and will support a significant enterprise SAP transformation initiative.
Who Will Be Most Successful
This opportunity is best suited for someone who has operated at the intersection of:

SAP S/4HANA + Computer System Validation + Pharmaceutical/Life Sciences Compliance

We are specifically interested in candidates who have personally developed or led validation strategies for major SAP transformation programs—not candidates whose experience has been limited to general software testing, quality assurance or documentation support.
Why Work With CornerStone Technology Talent Services?
CornerStone Technology Talent Services connects experienced technology professionals with high-impact opportunities across enterprise IT, digital transformation, cloud, data, cybersecurity and business applications.

Our recruiting team works closely with candidates throughout the process to ensure opportunities align with their technical background, professional goals and long-term career interests.

If your background includes SAP S/4HANA validation, CSV and regulated Life Sciences technology programs, we would like to hear from you.