Sr. CSV/CQV Specialist (Biotech)

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 per year, plus performance-based bonus and/or equity for eligible roles.

Company

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

What you will do

• Provide commissioning, qualification, requalification, and validation support for computerized systems in a cGMP clinical and commercial cell therapy manufacturing plant.
• Execute and manage CSV/CQV protocols, summary reports, data integrity activities, and related documentation.
• Manage complex CSV projects, status reporting, coordination, and vendor activities across multiple departments.
• Support technical and quality investigations, deviations, corrections, remediation activities, and CAPA plans.
• Create and review change controls, SOPs, risk assessments, FMEAs, periodic qualifications, project plans, master plans, and annual product reviews.
• Work with systems including SAP, MES, manufacturing and laboratory equipment, BAS, EDS, TrackWise, CMMS, and Maximo.

Requirements

• Bachelor’s degree in science, engineering, or an equivalent technical discipline.
• At least 8 years of relevant experience in CSV, CQV, engineering, quality assurance, manufacturing compliance, or related work.
• Expertise in GMP and data integrity requirements, including 21 CFR Parts 11, 210, and 211, EU Annex 11, ICH guidelines, and applicable FDA/EU guidance.
• Experience with cGMP and cGTP requirements related to CAR-T manufacturing, cell processing, or aseptic manufacturing.
• Experience authoring and executing batch records, SOPs, work instructions, validation protocols, and other controlled documentation.
• Ability to work onsite in Raritan, New Jersey, with authorization to work in the United States.

Culture & Benefits

• Medical, dental, and vision insurance with a 401(k) plan and company match fully vested from day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid vacation, personal time, sick time, floating holidays, and eleven company holidays.
• Additional benefits include flexible spending and health savings accounts, disability coverage, life insurance, legal assistance, commuter benefits, and family care resources.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible.