Sr. CQV Specialist (Cell Therapy)

Location: Onsite in Raritan, New Jersey, United States. Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.

Salary: $110,706–$145,303 USD base pay annually, plus performance-based bonus and/or equity for eligible roles.

Company

hirify.global is a global biotechnology company developing cell therapies, including CAR-T, TCR-T, and natural killer cell-based treatments.

What you will do

• Execute commissioning, qualification, requalification, validation, and associated maintenance activities for facility, equipment, systems, and processes.
• Manage complex CQV projects and coordinate deliverables with cross-functional teams, contractors, and vendors.
• Own technical and quality investigations, deviations, corrections, remediation efforts, and CAPA plans.
• Author and execute CQV protocols, summary reports, risk assessments, FMEAs, project plans, and related documentation with a focus on data integrity.
• Review and maintain change controls, SOPs, work instructions, batch records, and other regulated documentation.
• Present CQV work during regulatory and internal audits and train junior team members.

Requirements

• Bachelor’s degree in science, engineering, or an equivalent technical discipline.
• At least 7 years of relevant experience, preferably in aseptic manufacturing, cell therapy, testing, quality assurance, or manufacturing compliance.
• Knowledge of cGMP and cGTP requirements for CAR-T manufacturing or cell processing, including FDA/EU guidance and ICH standards.
• Experience with 21 CFR Parts 210, 211, and 1271; experience with Parts 600, 601, and 610 is preferred.
• Experience authoring and executing batch records, SOPs, work instructions, CQV protocols, and related documentation.
• Ability to use Microsoft Suite, ERP and CQV/testing systems such as Maximo, Siemens EMS, Comet, Kneat, Kaye AVS, or Kaye Valprobe, and to make critical decisions independently.

Culture & Benefits

• Full-time permanent employees receive medical, dental, and vision insurance.
• 401(k) retirement plan with company match fully vested from day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, family-care resources, and well-being programs.
• Contractors are not eligible for benefits through hirify.global.