Investigator, Operations Investigations

Role: Investigator, Operations Investigations at Johnson & Johnson's Raritan, NJ Cell Therapy facility, supporting GMP-regulated manufacturing of CAR T-cell therapy (CARVYKTI) for Multiple Myeloma. Responsibilities: lead and support investigations of manufacturing deviations, perform root cause analysis using tools like 5 Whys and Fishbone, assess impact on product quality and compliance, author investigation reports, support CAPAs, coordinate with cross-functional teams including Manufacturing and Quality, and prepare for regulatory audits. Qualifications: Bachelor's degree in Engineering, Science, or related field; at least 2 years of GMP environment experience, preferably in cell or gene therapy, biotech, or pharma manufacturing; experience supporting quality investigations and root cause analysis; strong technical writing and communication skills; familiarity with biologics, sterile manufacturing, and regulatory standards such as EU GMPs, CFR, USP. Preferred: experience with enterprise systems (eLIMS, SAP, TrackWise), supporting audits, and proficiency in investigation tools. HighValue: focus on cell/gene therapy, GMP manufacturing, investigational CAR-T products, regulatory compliance, and cross-functional collaboration. WorkSetup: based in Raritan, NJ, with up to 10% domestic/international travel.