# Director of Sterility Assurance at Johnson & Johnson

Johnson & Johnson is hiring a Director of Sterility Assurance. It pays $154k-$266k a year and Level rates it Little AI ●○○○; you can [apply on Johnson & Johnson](https://jobsbylevel.com/go/6208b701-da6c-4b81-8bde-1891524128f4?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. Raritan, New Jersey, United States of America.

## Details

- Company: [Johnson & Johnson](https://jobsbylevel.com/companies/johnson-johnson)
- AI level: AI Level 1 (score 38 out of 100)
- Location: Raritan, New Jersey, United States of America
- Salary: $154k-$266k
- Posted: November 11, 2026
- Apply: https://jobsbylevel.com/go/6208b701-da6c-4b81-8bde-1891524128f4?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=director-of-sterility-assurance-at-johnson-johnson-96b321

## Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for a Director of Sterility Assurance! This position will be performed fully onsite in Raritan, NJ. Position Summary The Director of Sterility Assurance, Cell Therapy Operations, provides site-level leadership and strategic direction for microbiological and virological control across cell therapy and lentiviral manufacturing at the Raritan facility. The role is accountable for establishing and sustaining an effective contamination control and sterility assurance program that protects product quality and patient safety, supports reliable operations, and maintains inspection readiness. The Director serves as the site’s primary subject matter expert and decision-maker for sterility assurance and contamination control and partners with Site and Global Quality, Manufacturing, Quality Control, Facilities and Engineering, MSAT, and Global Sterility Assurance/MQSA to align site practices with applicable health authority requirements, industry expectations, and scientific principles. Major Duties Site Sterility Assurance and Contamination Control Leadership Own the Raritan sterility assurance and contamination control program, serving as the primary site point of contact, subject matter expert, and decision-maker for related matters. Develop, implement, maintain, and continuously improve the site contamination control strategy, addressing viral, bacterial, fungal, mycoplasma, endotoxin, and other adventitious-agent risks. Provide governance and oversight for microbiological and virological control programs, including environmental monitoring, incoming-material testing, in-process testing, lot-release testing, and stability testing. Lead site risk assessments, gap assessments, mitigation plans, and sustainable remediation activities related to aseptic processing, biological contamination control, and sterility assurance. Provide strategic input to facility and equipment design, process design, material and personnel flows, cleaning and disinfection, segregation controls, maintenance, environmental monitoring, and microbiological testing. Lead the quality response to contamination events, sterility failures, microbiological excursions, and adverse trends; ensure scientifically sound investigations, root-cause analysis, and effective corrective and preventive actions (CAPAs). Review aseptic-processing and sterility-assurance performance indicators and trends; ensure timely, risk-based action plans and clear reporting to site and senior leadership. Support regulatory inspections, internal audits, mock inspections, due-diligence activities, and other compliance initiatives as the site sterility assurance SME. Monitor evolving regulatory requirements, industry expectations, and emerging technologies; translate relevant developments into timely, compliant, and practical site actions. Coach and train employees to strengthen understanding of biological risks, contamination control, good aseptic practices, and expected

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/director-of-sterility-assurance-at-johnson-johnson-96b321

Source: https://jobsbylevel.com/jobs/director-of-sterility-assurance-at-johnson-johnson-96b321

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