Investigator, Operations Investigations
About The Position
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. 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.
Requirements
- A minimum of a Bachelor's degree is required; a degree in Engineering, Science, Life Science, or a related technical discipline is preferred.
- Minimum of 2 years of relevant work experience in a GMP-regulated environment, with experience in cell therapy, gene therapy, biotechnology, biopharmaceutical, or pharmaceutical manufacturing preferred.
- Experience supporting or authoring quality investigations, including root cause analysis of nonconformance events.
- Ability to read, analyze, and interpret technical documents, SOPs, scientific and technical journals, legal documents, and government regulations or guidance documents, including EU GMPs, Annex 1, CFR, and USP.
- Strong technical writing fundamentals with the ability to author clear, complete, and compliant investigation documentation.
- Excellent written and oral communication skills, with a growing ability to present investigation findings to cross-functional stakeholders.
- Ability to follow defined procedures, manage routine tasks, and develop proficiency in investigation methods and quality systems.
- Basic understanding of risk management concepts and the ability to apply risk-based thinking to investigation impact assessments.
- Familiarity with biologics, sterile manufacturing, or cell and gene therapy manufacturing processes.
Nice To Haves
- Experience with one or more enterprise systems, including eLIMS, Salesforce, Maximo, EMS, TrackWise, Veeva, and/or SAP.
- Experience supporting internal and/or external regulatory audits or inspections.
- Familiarity with established root cause analysis tools, including 5 Whys and Fishbone.
- Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
Responsibilities
- 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 investigation reports that meet quality, regulatory, and business expectations.
- Own or support Corrective and Preventive Action CAPA investigations, including development of appropriate corrective actions and verification of supporting information.
- Coordinate with SMEs, Manufacturing, Quality, and other functional partners to gather required information, verify accuracy, and drive investigation alignment.
- Coordinate discussions to identify process improvements related to safety, environmental performance, quality, compliance, efficiency, and yield.
- Recognize and escalate potential compliance issues, recurring trends, and opportunities for process changes or improvement.
- Coordinate data collection and trend analysis in support of nonconformance management and audit activities.
- Support preparation for internal and external regulatory audits and inspections, including FDA and EMEA, and serve as a Subject Matter Expert as appropriate.
- Participate in investigation meetings, present investigation findings, and contribute to cross-functional decision-making.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
