Quality​/Validation Engineer

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

Industry: Pharmaceuticals / Life Sciences

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.

• 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.

• 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.