QA Validation Specialist II LVV (Biotech)

Location: Raritan, New Jersey, United States; primarily onsite with up to 5% local travel. Requires flexibility for first-shift 8-hour schedules Monday–Friday and occasional off-shift or weekend support.

Salary: $65,000–$117,000 annual base pay.

Company

Johnson & Johnson MedTech develops healthcare and pharmaceutical solutions, including cell and gene therapy products through its collaboration with Legend Biotech.

What you will do

• Provide quality oversight for analytical cell bank production, human apheresis cryopreservation, and viral vector testing in a controlled cGMP environment.
• Review environmental monitoring data, including viable and non-viable particulates, airflow, differential pressure, humidity, and temperature, for cleanroom release.
• Assess cleanroom performance against ISO 14644 and GMP Annex 1 requirements and evaluate contamination control and HVAC performance.
• Maintain validation protocols, results, deviations, corrective actions, and environmental monitoring records for compliance and audit readiness.
• Oversee equipment, facility, process, and computerized system validation activities, including URS, IQ, OQ, PQ, AVS, EMPQ, APS, and CSV deliverables.
• Review calibration and preventive maintenance status, investigate validation deviations, and approve equipment for production or testing after successful qualification.

Requirements

• Bachelor’s degree in Engineering, Science, or an equivalent technical field.
• At least 2 years of industry experience in a regulated manufacturing environment, preferably biotechnology or pharmaceuticals.
• Solid knowledge of current cGMP regulations and FDA/EU guidance.
• Ability to maintain accurate written records in paper-based and computerized quality systems.
• Strong organization, attention to detail, communication, teamwork, and independent working skills.
• Ability to work onsite in Raritan, New Jersey, with occasional local travel and off-shift or weekend support.

Nice to have

• Experience supporting clinical or GMP manufacturing operations and cleanrooms.
• Experience manufacturing cell and gene therapy products.
• Knowledge of Good Tissue Practices.

Culture & Benefits

• Inclusive work environment focused on healthcare innovation and patient impact.
• Medical, dental, vision, life insurance, disability, business accident, and group legal insurance may be available.
• Pension and 401(k) savings plan may be available.
• Paid vacation, sick time, holidays, work/personal/family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off are provided according to applicable policies.
• Eligible employees may participate in an annual performance bonus program.