Investigator, Operations Investigations

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: Supply Chain Manufacturing Job Sub Function: Manufacturing Pharmaceutical Process Operations Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for an Investigator, Operations Investigations to join our team in Raritan, NJ. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment. Are you interested in joining a team that is positively impacting patients' lives by ensuring reliable delivery of our high quality Innovative Medicine products? Apply today for this exciting opportunity to be part of the #CAR-T team! The Raritan CAR-T facility manufactures CARVYKTI™, a personalized autologous cell therapy product, in collaboration with our partner Legend Biotech, that is significantly improving the lives of patients with Multiple Myeloma. The manufacturing of this CAR-T therapy takes several days through various processing steps and quality control procedures. Our Raritan, NJ Cell Therapy facility is scaling up operational flows to serve more patients and meet the highest quality standards without compromising manufacturing efficiency. The Investigator, Operations Investigations will support and lead cross-functional investigation activities related to manufacturing nonconformances in a GMP-regulated biotechnology environment. This role is responsible for conducting structured root cause analysis, assessing product quality, safety, and compliance impact, authoring nonconformance reports, and supporting development of effective CAPAs. The Investigator will partner with Manufacturing, Quality, SMEs, and cross-functional stakeholders to ensure accurate, timely, and compliant completion of investigation activities.

Conduct and support end-to-end deviation and nonconformance investigations, including investigation planning, data gathering, root cause analysis, impact assessment, documentation, and closure. Perform structured root cause analyses using established tools such as 5 Whys and Fishbone, with appropriate coaching or independent ownership based on investigation complexity. Assess the impact of nonconformance events on product quality, patient safety, compliance, and process performance. Author clear, accurate, and compliant nonconformance