Senior CQV Lead for GMP Cell Therapy Validation

Katalyst CRO; Raritan (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO seeks a Senior CQV Specialist to lead commissioning, qualification, and validation activities for facility, equipment, and computerized systems supporting GMP cell therapy manufacturing.

The role requires owning qualification strategy and execution with a risk-based validation approach aligned to USP, GAMP 5, and industry best practices; you will drive deviations and investigations, author protocols/reports, and support inspection readiness.

Qualifications

• 8+ years of CQV/validation experience in GMP pharmaceutical, biotech, or cell therapy manufacturing (cell therapy strongly preferred).
• Hands-on experience qualifying facility, equipment, and computerized systems.
• Strong working knowledge of USP, GAMP 5, and risk-based validation methodologies.
• Demonstrated experience owning validation programs, writing protocols, executing testing, and managing deviations.
• Ability to understand complex scope, define qualification impact, and implement compliant execution strategies.
• Excellent communication skills and ability to lead independently in fast paced GMP environments.

Responsibilities

• Lead and own CQV activities across facility, QC, process, and computerized systems, including cleanrooms, smoke studies, and qualified equipment.
• Develop and execute robust, risk-based qualification strategies grounded in USP, GAMP 5, and system impact assessments (ISP guidelines).
• Author and execute validation plans, protocols, reports, risk assessments, and GxP documentation.
• Drive execution activities, proactively resolving issues, deviations, and remediation items during qualification.
• Lead deviation investigations, impact assessments, and corrective actions.
• Support qualification of cell therapy-specific and QC systems such as qPCR, BacT, Faxitron, and microplate readers.
• Quickly onboard to new projects and scopes, independently managing execution from planning through approval.
• Represent CQV activities during internal and regulatory inspections as needed.

Skills

CQV/Validation Leadership

GMP Biotech / Cell Therapy

Risk-based Validation

Planning & Execution

Technical Writing

Regulatory Readiness

Deviation Management

Job description

Katalyst CRO seeks a Senior CQV Specialist to lead commissioning, qualification, and validation activities for facility, equipment, and computerized systems supporting GMP cell therapy manufacturing.

The role requires owning qualification strategy and execution with a risk-based validation approach aligned to USP, GAMP 5, and industry best practices; you will drive deviations and investigations, author protocols/reports, and support inspection readiness.