Quality/Validation Engineer

Location: Raritan, New Jersey, 08869 | Work Type: Hybrid | Employment Type: Full-time

Industry: Pharmaceuticals / Life Sciences

Job Summary

AAsys Technologies LLC is seeking a Quality/Validation Engineer with hands-on expertise in GxP-regulated environments and Computer System Validation (CSV). This role involves full lifecycle validation of systems such as ERP, WMS, and R&D platforms in accordance with 21 CFR Part 11, GAMP 5, and QMS standards.

Key Responsibilities

• Serve as a Quality Engineer with expert-level knowledge of GxP regulations and Computer System Validation (CSV) processes,

•  Lead and manage validation activities for GxP-regulated systems, including ERP, WMS, and R&D platforms, across the full System Development Life Cycle (SDLC).

• Author and review all required CSV deliverables, including: Compliance Plans, URS, FRS, Test Protocols, Traceability Matrices, Validation Summary Reports.

•  Apply risk-based validation strategies in accordance with 21 CFR Part 11, GAMP 5, FDA, and QMS standards.

• Apply risk-based validation strategies in accordance with 21 CFR Part 11, GAMP 5, FDA, and QMS standards.

• Plan and execute Backup & Restore validation strategies to ensure business continuity and data integrity for GxP systems.

• Perform and manage change control activities, ensuring complete traceability, risk assessment, and compliance throughout the lifecycle.

• Guide and educate Business SMEs on refining user stories and translating business requirements into compliant technical specifications.

• Create and review Standard Operating Procedures (SOPs) and Work Instructions (WIs) for validated systems and processes.

• Plan and conduct User Acceptance Testing (UAT), including both manual and automated testing, regression testing, and dry runs in coordination with QA and Automation teams.

• Support post-go-live phases by ensuring validated systems remain in a controlled and compliant state and are ready for audits or inspections

• Produce and communicate validation metrics, dashboards, and transparency reports to ensure visibility of testing progress, issue tracking, and compliance status.

• Interact and lead discussions with technology partners and business stakeholders to align on system validation strategy, requirements, and GxP compliance goals.

• Demonstrate excellent communication, leadership, and independent work capability, taking ownership of validation planning, execution, and stakeholder engagement.

Requirements

• Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Pharmaceutical Engineering, or Drug Regulatory Affairs.
• Strong knowledge of 21 CFR Part 11, GAMP 5, FDA QMS.
• Minimum 8–10 years of experience in CSV and GxP systems validation.
• Excellent communication, leadership, and documentation skills.

Ready to Apply?

Send your resume to info@aasystechnologies.com