Cqv Engineer Cell Gene Therapy

Job Title: CQV Engineer Cell & Gene Therapy
Company: Intellectt INC
Location: Hopkinton, MA
Experience: 7+ years
Pay Range: $45 - $50/hr on W2

Job Summary

A cell and gene therapy CDMO is seeking an experienced CQV Engineer to independently support commissioning, qualification, and validation activities for new equipment in a renovated GMP manufacturing suite. The role includes PPQ protocol execution, equipment qualification, chamber mapping, facility requalification, and preparation of validation documentation.

Key Responsibilities

• Execute Process Performance Qualification (PPQ) protocols and support qualification of cell therapy equipment, including Eppendorf systems, incubators, freezers, chambers, and analytical instruments.
• Develop, execute, and complete qualification protocols and summary reports.
• Perform chamber mapping and temperature distribution studies.
• Support requalification of GMP facilities and associated equipment.
• Document test results, investigate qualification discrepancies, and coordinate resolution with Engineering, Manufacturing, and Quality teams.
• Use ValGenesis to execute and maintain validation documentation.
• Manage assigned CQV activities independently while meeting project timelines and GMP requirements.

• 7+ years of hands-on CQV experience in GMP pharmaceutical or biotechnology environments.
• Experience executing PPQ protocols for cell therapy equipment.
• Experience qualifying incubators, freezers, chambers, and analytical equipment.
• Experience performing chamber mapping and facility or equipment requalification.
• Strong technical writing skills, including qualification protocols and summary reports.
• Experience with ValGenesis; hands-on protocol execution is highly preferred.
• Ability to work independently and collaborate with cross-functional teams.

Preferred Experience

• Qualification of Eppendorf systems.
• Cell and gene therapy manufacturing or CDMO experience.
• CQV support for renovated manufacturing suites or new equipment installations.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws
Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

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