CSV Engineer

Katalyst CRO; Raritan (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

Katalyst CRO in Raritan, NJ, is seeking an experienced CSV validation professional to lead end-to-end CSV activities in adherence to regulatory standards. The candidate will support business separations for large GxP systems and define risk-based validation strategies. Experience in Pharma or biotech, strong leadership skills, and a comprehensive understanding of FDA regulations are essential for this role. Collaboration with global teams is integral, ensuring compliance with quality standards throughout the validation process.

Qualifications

• 710 years in CSV / Validation roles.
• Experience in Pharma / Biotech / Medical Devices industry.
• Deep understanding of FDA regulations & GxP standards.

Responsibilities

• Lead end-to-end CSV activities.
• Support business separation for large GxP systems.
• Define & implement risk-based validation strategies.

Skills

CSV leadership

Regulatory compliance

Risk-based validation strategies

Collaboration with teams

Project management

Education

710 years in CSV / Validation roles

Experience in Pharma / Biotech / Medical Devices

Job description

Roles & Responsibilities

• Lead end-to-end CSV activities (inventory assessment remediation disposition)
• Support business separation for large GxP systems
• Define & implement risk-based validation strategies
• Review & approve test plans, UAT scripts, validation documents
• Ensure compliance with regulatory & quality standards
• Provide guidance, escalation & leadership to validation teams
• Collaborate with global & remote teams

Education & Experience

• 710 years in CSV / Validation roles
• Experience in Pharma / Biotech / Medical Devices industry
• Proven experience in regulated environments (FDA/GxP)
• Strong expertise in CSV (Computer System Validation) in GxP environments
• Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation)
• Hands-on in Acquisitions / Divestitures / Business Separation projects
• Deep understanding of FDA regulations & GxP standards
• Experience with Risk-based validation approach
• Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs)
• Experience in UAT, Traceability Matrix & QA methodologies
• Ability to lead teams & manage multiple projects