Investigator I/II (Biotechnology)

Location: Onsite in Raritan, New Jersey, United States

Base pay: $72,791–$102,705 per year. Performance-based bonus and/or equity may be available for eligible roles.

Company

hirify.global is a global biotechnology company developing cell therapies, including CAR-T, TCR-T, NK-cell, and other platforms for serious diseases.

What you will do

• Lead end-to-end investigations involving manufacturing, facilities, engineering, equipment, validation, and environmental monitoring.
• Review manufacturing, maintenance, calibration, validation, environmental monitoring, and quality records to assess product quality, patient safety, data integrity, and regulatory impact.
• Perform structured root cause analyses, risk assessments, product impact assessments, and batch disposition support.
• Develop and own CAPAs, effectiveness checks, investigation reports, and quality records in the eQMS.
• Lead investigation meetings and collaborate with subject matter experts, Quality leads, and cross-functional stakeholders.
• Support audits and regulatory inspections, identify recurring quality issues, and contribute to continuous improvement.

Requirements

• BS/BA in engineering, science, or a related field.
• 4–6 years of cGMP experience in biotechnology, biopharmaceutical, pharmaceutical, or another regulated industry, and/or 2–4 years of quality investigation experience.
• Experience with moderate- to high-complexity investigations, risk assessments, root cause analysis, CAPAs, and product impact assessments.
• Working knowledge of cGMP regulations, quality systems, data integrity principles, and electronic quality management systems.
• Technical knowledge of biologics, cell therapy, gene therapy, or pharmaceutical manufacturing processes.
• Applicants must be authorized to work in the United States; employment eligibility will be verified through Form I-9 and E-Verify.

Culture & Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with a company match that fully vests on 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, commuter benefits, family care resources, and well-being programs.
• Benefits are available exclusively to permanent full-time employees; contractors are not eligible.