CSV Engineer

Katalyst CRO; Raritan (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a seasoned validation professional with exposure to CSV, quality assurance, and GxP systems in a US-based context. The role emphasizes independent leadership across the SDLC, with responsibilities spanning documentation, regulatory readiness, and cross-functional collaboration.

The ideal candidate will bring extensive experience in GMP environments, strong communication skills, and the ability to mentor diverse teams while coordinating multiple projects and maintaining

Qualifications

• Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision.
• 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.

Responsibilities

• Lead validation activities across the SDLC for GxP systems.
• Support global and regional GxP computerized systems.
• Develop and review validation deliverables and documentation.
• Apply risk-based validation and risk management practices.
• Mentor Senior and Junior consultants and coordinate cross-functional teams.
• Communicate risks and progress to stakeholders and manage issues.

Skills

CSV/Quality expertise

Independent validation leadership

GxP systems knowledge

Regulatory compliance

Risk-based validation

Stakeholder communication

Team mentoring

Tools

Jira

Xray

qTest

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.
• " 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.