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Job Title - CSV Engineer
Location – Raritan, NJ (Hybrid)
W2/C2C
Job Details:
Role Overview:
Job Title - CSV Engineer
Location – Raritan, NJ (Hybrid)
W2/C2C
Job Details:
Role Overview:
- Request for Technology Quality Manufacturing and MES Services - 100% allocation / North America (Onshore).
- 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.