JSR Micro, Inc.

SAP Principal IT Validation, Compliance

JSR Micro, Inc.

full-time

Posted on:

Location Type: Remote

Location: North Carolina • United States

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Salary

💰 $133,000 - $183,700 per year

Job Level

Lead

About the role

  • Provide global oversight for SAP system validation across all SAP modules (e.g. SAP S/4HANA, MM (IM), EWM, QM, PP, GRC, and Solution Manager, etc.) and support integrations.
  • Lead validation direction and approval of SAP lifecycle deliverables including URS, FRS/FS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ, CSV Plans, Validation Summaries, and Release Documentation.
  • Manage and provide oversight of managed validation services for SAP implementation, upgrade, and enhancement projects.
  • Provide SAP validation review and approval for SAP-related change controls, CAPAs, and deviations, ensuring all impacts are properly assessed, documented, and resolved.
  • Support SAP data integrity initiatives , including validation and compliance of SAP controls, audit trails, electronic signatures, segregation of duties (SoD), access controls, and data lifecycle governance.
  • Provide SAP compliance expertise and input for global Policies, SOPs, and Templates for SAP enterprise systems.
  • Serve as a key SAP validation SME supporting audits, regulatory inspections, and internal quality reviews.

Requirements

  • 15+ years experience in a cGMP environment in computer system validation with demonstrated career growth and achievements.
  • Direct SAP validation experience in an FDA-regulated manufacturing or CDMO environment.
  • Strong working knowledge of SAP lifecycle validation (implementation, upgrade, change control, and periodic review).
  • Expert understanding of 21 CFR Part 11, EU Annex 11 , and regulatory guidance on Data Integrity as it relates to SAP systems.
  • Experience with SAP-specific compliance controls such as: SAP GRC (Access Control, Process Control, Risk Management)
  • SAP security & role design
  • Audit trails and change logs in SAP
  • SAP transport management and change management
  • Strong collaboration skills with SAP functional and technical teams, IT, and Quality stakeholders.
Benefits
  • annual bonus structure
  • medical/dental/vision coverage
  • paid PTO and holidays
  • sabbatical program
  • 401(k) matching with 100% vesting in 60 days
  • employee recognition programs
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAP S/4HANASAP MMSAP EWMSAP QMSAP PPSAP GRCcomputer system validationSAP lifecycle validationdata integrityaudit trails
Soft Skills
collaborationleadershipoversightcommunicationproblem-solving