CQV Specialist

JobDiva, Inc.; Dallas (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a CQV Specialist to lead commissioning, qualification, and validation activities for GMP cell therapy manufacturing, including facility, equipment, and computerized systems.

You will own qualification strategy, write protocols, execute testing, and manage deviations in a fast-paced GMP environment, with strong emphasis on risk-based methodologies aligned with USP 1058 and GAMP 5.

Qualifications

• 8+ years of CQV/validation experience in GMP pharmaceutical, biotech, or cell therapy manufacturing.
• Hands-on experience qualifying facility, equipment, and computerized systems.
• Strong working knowledge of USP <1058>, 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 <1058>, 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

USP 1058

GAMP 5

risk-based validation

validation program ownership

document writing

Tools

qPCR

BacT

Faxitron

Microplate readers

Job description

Job description:

• We are seeking a 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 <1058> , 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 <1058> , 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 <1058> , 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.