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CSV Engineer /Hybrid
Job
E-Solutions Inc.
Rahway, NJ (In Person)
Full-Time
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Job Description
CSV Engineer /Hybrid (Rahway, NJ, 07065) | 06/10/26 Job Description
- Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience.
- Proven experience with Manufacturing, MES, and Data Platform Applications, including support for global and regional GxP computerized systems.
- Deep knowledge of GxP compliance, FDA/Global regulations, and Inspection Readiness.
- Expertise in validation documentation and deliverables, including review of compliance plans, requirements, design specs, test protocols, test scripts, defects, traceability, reports and system procedures.
- Demonstrated application of risk-based validation and risk management practices.
- Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants).
- Strong project coordination and stakeholder communication skills, including managing risks, issues, and status reporting.