Overview
On Site
Full Time
Skills
SAP Implementation
Software Development Methodology
Risk Assessment
Test Scripts
Change Control
Incident Management
Corrective And Preventive Action
Collaboration
Stakeholder Management
Quality Assurance
Auditing
Lifecycle Management
Management
Continuous Improvement
Computerized System Validation
Pharmaceutics
Life Sciences
Medical Devices
SAP ECC
SAP HANA
SAP
GxP
SAP QM
SAP MM
SAP WM
URS
FRS
IQ
OQ
PQ
GAMP
Regulatory Compliance
Change Management
Data Integrity
Security Controls
Documentation
GDP
Problem Solving
Conflict Resolution
Communication
Stakeholder Engagement
Job Details
Job Description:
- We are seeking an experienced SAP Validation Lead to drive Computer System Validation (CSV) efforts for SAP systems in a regulated environment. The ideal candidate will ensure SAP implementations and enhancements comply with GxP, FDA 21 CFR Part 11, Annex 11, and industry validation standards.
- This role requires deep expertise in SAP validation, SDLC methodologies, risk-based validation approaches, and change management processes. You will collaborate closely with Business, IT, QA, and Regulatory stakeholders to ensure compliance, system integrity, and data reliability.
- SAP System Validation & Compliance.
- Lead end-to-end validation of SAP systems in line with GxP, 21 CFR Part 11, Annex 11, and ALCOA+ principles.
- Develop and execute validation strategies, IQ, OQ, PQ protocols, and test scripts.
- Ensure documentation aligns with GAMP 5, FDA, and industry standards.
- Validation Documentation & Risk Assessment.
- Author, review, and approve URS, FRS, Risk Assessments, Validation Plans, Test Scripts, and Reports.
- Conduct impact assessments, risk evaluations, and periodic system reviews.
- Change Control & Incident Management.
- Lead Change Control assessments for SAP updates, patches, and customizations.
- Ensure incident management, deviations tracking, and CAPA resolution.
- Collaboration & Stakeholder Management.
- Partner with Business, IT, and QA teams to align validation with business needs.
- Act as the SAP Validation SME during internal and external audits.
- System Decommissioning & Lifecycle Management.
- Oversee system decommissioning with full compliance and documentation.
- Drive continuous improvement for validation processes.
- 8+ years in SAP validation, compliance, and CSV within Pharma, Life Sciences, or Medical Devices.
- Strong knowledge of SAP ECC, S/4HANA, SAP GxP, SAP QM, SAP MM, SAP WM.
- Expertise in validation deliverables (URS, FRS, IQ, OQ, PQ, Validation Reports).
- Experience with GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+ compliance.
- Hands-on with change management, incident tracking, and system reviews.
- Strong understanding of data integrity, security controls, and electronic record-keeping.
- Excellent documentation skills with Good Documentation Practices (GDP).
- Strong problem-solving, communication, and stakeholder engagement abilities.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.