SAP S/HANA Validation SME
Job in
Foster City, San Mateo County, California, 94420, USA
Listed on 2026-09-26
Listing for:
CornerStone Technology Talent Services
Full Time
position Listed on 2026-09-26
Job specializations:
-
IT/Tech
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
Good day! We are seeking an experienced SAP S/4
HANA Validation SME (Life Sciences) to support a large-scale enterprise transformation within the Life Sciences industry.
The ideal candidate combines extensive Computer System Validation (CSV) expertise with hands-on experience supporting SAP S/4
HANA programs in regulated GxP environments.
Foster City, CA (Hybrid - three days onsite per week)
Duration12 Months (Possible Extension)
Work AuthorizationU.S. Citizens and Green Card holders only; W2 employment required
Key Responsibilities- Lead the validation strategy for a global SAP S/4
HANA transformation. - Define risk-based validation approaches for GxP and non-GxP systems and processes.
- Create, review and approve validation lifecycle documentation.
- Incorporate CSV deliverables, quality gates and milestones into project plans.
- Assess system changes and determine validation requirements based on regulatory risk.
- Ensure compliance with internal quality standards and applicable health authority regulations.
- Partner with Quality, Compliance, IT, SAP functional teams and business stakeholders.
- Communicate validation risks, requirements and recommendations to senior leadership.
- Improve CSV processes, procedures and related SOPs.
- Approximately 12+ years of professional experience, including substantial work within pharmaceutical, biotechnology, Life Sciences or another regulated industry.
- Extensive hands-on experience with Computer System Validation.
- Experience validating SAP enterprise applications, ideally SAP ECC and SAP S/4
HANA. - Experience supporting a major SAP S/4
HANA implementation, migration or transformation. - Strong knowledge of GxP, 21 CFR Part 11, GAMP 5, data integrity, risk management, QMS and SDLC controls.
- Experience developing and approving validation documentation across the system lifecycle.
- Strong understanding of risk-based testing and GxP versus non-GxP validation requirements.
- Excellent communication, stakeholder-management and client-facing skills.
- Experience with SAP Solution Manager, ChaRM, GRC, MDG, RISE, DRC, data migration, master data or SAP functional work streams is highly desirable.
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