SAP S/4HANA Validation Lead

We are seeking an experienced SAP S/4HANA Validation Lead to support the validation of a new SAP S/4HANA environment for a major implementation project. The ideal candidate will lead Computer System Validation (CSV) activities to ensure the system complies with regulatory, quality, and business requirements throughout the implementation lifecycle. This role requires strong expertise in SAP S/4HANA implementations, Computer System Validation (CSV), and validation documentation within regulated environments., Lead validation activities for a new SAP S/4HANA implementation. Develop and execute validation strategies, plans, and protocols. Prepare and review validation deliverables, including: Validation Plan (VP) User Requirements Specification (URS) Functional Specification (FS) Risk Assessment (RA) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Traceability Matrix (TM) Validation Summary Report (VSR) Coordinate with business stakeholders, IT teams, SAP functional consultants, and Quality Assurance teams. Ensure compliance with GxP, FDA 21 CFR Part 11, GAMP 5, and ALCOA+ principles. Support testing, defect management, issue resolution, and change control activities. Provide validation leadership throughout the SAP S/4HANA implementation lifecycle.

8+ years of Computer System Validation (CSV) experience. Hands-on experience validating SAP S/4HANA implementations. Strong understanding of GxP validation methodologies. Experience creating and reviewing validation documentation. Knowledge of FDA regulations, 21 CFR Part 11, GAMP 5, and ALCOA+ principles. Experience working within pharmaceutical, biotechnology, or life sciences environments. Strong communication and stakeholder management skills. Ability to work onsite in Bridgewater, NJ, three days per week.