CSV Consultant

Raas Infotek; Raritan (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Raas Infotek is looking for a qualified candidate for a role focused on Technology Quality Manufacturing and MES Services. This position requires a strong CSV and Quality expertise for leading validation activities across the SDLC in GxP systems with a desire for 7-10 years of relevant experience.

Key responsibilities include project coordination, managing stakeholder communication, and expertise in GxP compliance documentation. The role also requires effective leadership skills and the ability to collaborate with remote teams.

Qualifications

• 7-10 years of experience in Technology Quality Manufacturing, particularly with GxP systems.
• Independent leadership in validation activities across the SDLC.
• Expertise in validation documentation including compliance plans and test reports.

Responsibilities

• Lead validation activities across the SDLC for GxP systems.
• Manage project coordination and stakeholder communication.
• Write and review documentation such as Compliance Plans and Test Reports.

Skills

CSV expertise

Quality expertise

GxP compliance

Leadership skills

Project coordination

Stakeholder communication

Agile Tools

Tools

Jira

Xray

qTest

Job description

• Request for Technology Quality Manufacturing and MES 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 from J&J is desirable.