CQV Specialist

Katalyst CRO; Jacksonville (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

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

You will own qualification strategy, develop robust, risk-based validation, and ensure compliance with USP, GAMP 5, and industry best practices while guiding deviations, investigations, and regulatory interactions.

Qualifications

• 8+ years CQV/validation in GMP pharma, biotech, or cell therapy.
• Hands-on qualification of facilities, equipment, and computerized systems.
• Knowledge of USP, GAMP5 and risk-based validation methods.
• Experience owning validation programs, writing protocols, and testing.
• Excellent communication and ability to lead in fast-paced GMP environments.

Responsibilities

• Lead CQV activities across facility, QC, processes and computerized systems.
• Develop and execute qualification strategies grounded in USP, GAMP5, ISP guidelines.
• Author and execute validation plans, protocols, reports and risk assessments.
• Drive execution, resolve deviations and remediation items during qualification.
• Represent CQV during inspections as needed.

Skills

CQV/Validation Experience

GMP Knowledge

USP & GAMP5 Knowledge

Risk-Based Validation

Validation Planning & Protocol Writing

Deviations & CAPA

Communication & Leadership

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.