JSR Micro, Inc.

Driving innovation in semiconductor materials solutions while always maintaining an uncompromising focus on quality.

SAP Principal IT Validation, Compliance

ComplianceComplianceFull TimeRemoteTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

39 days ago

Salary

$133K - $183.7K / year

15 yrs expEnglish

Job Description

• 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.

Job 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

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