CSV Engineer

Job Title - CSV Engineer (SAP ERP/MES)

Location – Raritan, NJ (Day-1 Onsite/Hybrid)

Job Details: 

Role Overview:

Request for Technology Quality Manufacturing and MES or SAP ERP Services - 100% allocation / North America (Onshore). 

Must have: 

• 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.
• Experience in writing documentation (i.e. Compliance Plan, Test Plans, Test Reports, Compliance Summary Reports, and SOPs). 
• Knowledge of Agile Tools (e.g., Jira, Xray, qTest, etc.). 
• Ability to build collaborative partnerships, work as a team player and support execution of business objectives across teams, including timely escalations to TQ manager. 
• Primary Language required: English. Strong verbal and written communication skills. 
• Ability to work with dispersed/remote teams and support several projects simultaneously. 
• Experience with Acquisitions/Separations/Divestiture efforts is desirable. 

Thanks & Regards
Darshan Neema
Client Account Manager, KTEK Resourcing
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