CQV Specialist

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

• We are seeking a Senior CQV Specialist to lead commissioning, qualification, and validation activities for facility, equipment, and computerized systems supporting GMP cell therapy manufacturing.


• This individual will own qualification strategy and execution, ensuring compliant, risk-based validation aligned with USP , GAMP 5, and industry best practices.

Job Description

We are seeking a Senior CQV Specialist to lead commissioning, qualification, and validation activities for facility, equipment, and computerized systems supporting GMP cell therapy manufacturing.

This individual will own qualification strategy and execution, ensuring compliant, risk-based validation aligned with USP , GAMP 5, and industry best practices.

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.

Requirements

• 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.